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Company Announcement
When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.
Mondelēz Global LLC Conducts Nationwide Voluntary - Recall of Oreo Fudge Cremes Product Sold in the U.S. Recall Due to Milk Allergen Not Listed in Ingredient Line
For Immediate Release
October 28, 2016
Contact
Consumers
Consumer Relations
1-855-535-5948
Media
Laurie Guzzinati
+1-847-943-5678
Announcement
View Product Photos
East Hanover, N.J. – Mondelez Global LLC announced today a nationwide voluntary recall in the United States, including the U.S. Territories of Puerto Rico, St. Croix and St. Thomas, of certain Oreo Fudge Cremes product, Original and Mint varieties, due to milk allergen not being declared in the ingredient list.
Mondelez Global LLC is taking this action out of an abundance of caution. Consumers may be informed about the potential presence of milk by an allergen advisory statement already included on the label (“Manufactured on equipment that processes milk....”). People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume this product.
The following product is being recalled:
Description
Retail UPC
Best When Used By Dates
Oreo Fudge Cremes, Original variety (11.3 oz package)
0 44000 02694 3
19 AUG 16
20 AUG 16
14 SEP 16
13 OCT 16
14 OCT 16
17 OCT 16
(see code date on bottom left corner on back of package)
Oreo Fudge Cremes, Mint variety (11.3 oz. package)
0 44000 02696 7
20 AUG 16
21 AUG 16
14 SEP 16
15 SEP 16
16 SEP 16
17 OCT 16
18 OCT 16 (see code date on bottom left corner on back of package)
This recall is limited exclusively to this Oreo Fudge Cremes product, Original and Mint varieties, sold in the U.S., including the U.S. Territories of Puerto Rico, St. Croix and St. Thomas, and no other products are included in this recall. To date, one report of an allergic reaction has been received related to the above-listed “Best When Used By” dates. This recall is a result of analysis conducted by the FDA related to this product.
Consumers who have this product should not eat it and should discard any products they may have. Consumers can contact the company at 1-855-535-5948, 24 hours a day to get more information about the recall, and Consumer Relations specialists are available Monday – Friday, 9 a.m. to 6 p.m. ET.
John
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HeartWare Ventricular Assist Device (HVAD) Pumps by HeartWare Inc.: Class I Recall - Loose Connectors May Prevent Alarm from Sounding
AUDIENCE: Risk Manager, Nursing
ISSUE: HeartWare Inc. is recalling the HVAD controller due to a loose power connector which may cause the rear portion of the pump's driveline connector to become separated from the front portion of the driveline connector. A loose connector may allow moisture to enter the controller causing corrosion, electrical issues, reduced speaker volume and connection failures. If the speaker volume is decreased, the patient may not hear the alarm. If there is a loss of connection, the pump may stop which could cause serious adverse health consequences, including death.
Serial Numbers: HW001 to HW11270, and HW20001 to HW 20296
Product Codes: 1100, 1101, 1102, 1103, 1104, 1205
Manufacturing Dates: March 6, 2006 to October 17, 2016
BACKGROUND: The HVAD helps deliver blood from the heart to the rest of the body. It is used in patients who are at risk of death from end-stage left ventricular heart failure and who are waiting for a heart transplant. The system includes a pump implanted in the space around the heart (pericardium) and a controller that controls the speed and function of the pump. The HVAD is designed for use both in and out of hospital settings, including during patient transport.
RECOMMENDATION: On June 8, 2016, HeartWare Inc. sent an "Urgent Medical Device Correction" letter to affected customers. The letter instructed providers who care for these patients to:
Remind patients about the safe use of the HVAD System, particularly with regard to moisture and proper connection to power and data sources.
Inspect controllers for loose connectors by gently pressing on each connector and feeling for atypical movement.
If a loose connector is identified, replace with a controller from inventory and contact your local HeartWare representative
If the loose controller is the patient's primary controller, perform a careful benefit risk analysis before using the device.
Sign and return the "Acknowledgement Form" to HeartWare Quality Compliance via email at FSCA@heartware.com, or fax it to (305) 364-2665 within 30 days.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
Complete and submit the report Online: www.fda.gov/MedWatch/report
Download form http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch safety alert, including a link to the Recall notice, at:
John
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Company Announcement
When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.
Back to Nature Issues a Product Recall and Allergy Alert for Chocolate Chunk Cookies, Mini Chocolate Chunk Cookies and Chocolate Granola Due to Undeclared Milk
For Immediate Release
October 27, 2016
Contact
Consumers
844-275-5845
Media
Eva Pereira
781-559-0424
Announcement
View Product Photos
Naples, FL – Back to Nature Foodsdisclaimer icon, LLC is voluntarily recalling four (4) products because those products contain chocolate purchased from a third party supplier which was found to contain undeclared Milk that is not listed as an ingredient on the label.
Products affected are:
Back to Nature Products
UPC
Best By Date
Chocolate Delight Granola 11oz
19898-01201
12/25/16 - 7/27/17
Dark Chocolate Coconut Granola 11oz
19898-01225
5/9/17 - 8/14/17
Chocolate Chunk Cookies 9.5oz
19898-01100
5/8/17 – 5/12/17
Mini Chocolate Chunk Cookies 6 x 1.25oz
19898-01114 (Tray)
19898-01115 (Pouch)
5/1/17
Mini Chocolate Chunk Cookies 100 x 1.25oz
19898-01148 (Case)
19898-01115 (Pouch)
5/1/17
Mini Chocolate Chunk Cookies 9 x 2.5oz
19898-01144 (Caddy)
19898-01143 (Pouch)
5/1/17
Persons who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they consume this product.
The affected Cookie and Granola products were distributed to retail stores nationwide. No other products or best by dates are affected.
Best by date codes can be found on the top of the bottom of the Granola packaging, the top of the Chocolate Chunk 9.5 oz carton, and on the back of the Mini Chocolate Chunk Tray or individual package.
Consumers who have purchased the Back to Nature Chocolate Chunk Cookies, Mini Chocolate Chunk Cookies, Chocolate Delight Granola, or Dark Chocolate Granola with the UPC numbers and dates noted, and have an allergy to milk, should destroy the product they have or are urged to return the product to the place of purchase for product replacement or refund.
Consumers with questions may call Back to Nature’s Consumer Relations Center at 844-275-5845. The center is open Monday through Friday from 9:00 a.m. to 5:00 p.m. Eastern. Consumers also may contact the center via e-mail by visiting the Contact Us page at Back to Nature Foods for a replacement coupon.
No other Back to Nature brand products are included in this recall.
This voluntary recall is being conducted with the knowledge of the U.S. Food & Drug Administration.
The company has also reported the recall to FARE (Food Allergy Research & Education) and is placing a notification on the FAACT website www.foodallergyawareness.org.
About Back to Nature Foods
Headquartered in Naples, FL, Back to Nature Foods is a leading producer of Cookies, Crackers, Granola, Cereal, Juice and Soups in the United States. Back to Nature Foods Company, LLC is a manufacturer of all-natural and organic cookies, crackers, granolas, nuts, trail mixes and juices. Back to Nature® has made nutritious foods with simple ingredients for 53 years.
John
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News Release
Gaiser's European Style Provision Inc. Recalls Chicken and Pork Bologna Products Due to Misbranding, Undeclared Allergens, and Being Formulated with Uninspected Meat and Poultry Products
Class I Recall
101-2016
Health Risk: High
Oct 26, 2016
Congressional and Public Affairs
Maria Machuca
(202) 720-9113
WASHINGTON, Oct. 26, 2016 – Gaiser’s European Style Provision Inc., a Union, N.J. establishment, is recalling approximately 3,895 pounds of chicken and pork bologna products due to misbranding, undeclared allergens, and being formulated with meat and poultry products that were not federally inspected, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The products may contain nonfat dry milk, a known allergen which is not declared on the finished product label.
The bologna items were produced on various dates from Oct. 6, 2016 to Oct. 20, 2016. The following products are subject to recall:
View Labels PDF only
1-lb. chubb artificial casing containing “Gaiser’s RUSSIAN BRAND PROFESSORSKAYA BOLOGNA” pork bologna with various packaging dates from Oct. 10, 2016 to Oct. 21, 2016.
10-lb. chubb artificial casing containing “Gaiser’s PROFESSORSKAYA” pork bologna with various packaging dates from Oct. 10, 2016 to Oct. 21, 2016.
1-lb. chubb artificial casing containing “NetCost Market PROFESSORSKAYA BRAND BOLOGNA” with various packaging dates from Oct. 10, 2016 to Oct. 21, 2016.
1-lb. chubb artificial casing containing “Gaiser’s CHICKEN BOLOGNA” with various packaging dates from Oct. 10, 2016 to Oct. 21, 2016.
3-lb. chubb artificial casing containing “Gaiser’s CHICKEN BOLOGNA” with various packaging dates from Oct. 10, 2016 to Oct. 21, 2016.
1-lb. chubb artificial casing containing “NetCost Market CHICKEN BOLOGNA” with various packaging dates from Oct. 10, 2016 to Oct. 21, 2016.
The products subject to recall bear establishment number “EST. 5385 or P-5385” inside the USDA mark of inspection. These items were shipped to retail locations and/or for institutional use in California, Minnesota, New Jersey, New York and Washington.
The problem was discovered during a Food Safety Assessment conducted by FSIS personnel.
There have been no confirmed reports of illness or adverse reactions due to consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider.
Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.
FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers. When available, the retail distribution list(s) will be posted on the FSIS website at www.fsis.usda.gov/recalls.
Consumers and members of the media with questions about the recall can contact Igor Denisenko, Gaiser’s European Style Provision Inc.’s plant manager, at (908) 686-3421.
John
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Company Announcement
When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.
Stewart's Shops Issues Allergy Alert On Undeclared Milk In Sportade Fruit Punch
For Immediate Release
October 26, 2016
Contact
Consumers
Stewart's Consumer Affairs Department
518-581-1200 ext. 2130
Monday-Friday, 8am-4:30 pm
Announcement
View Product Photos
Saratoga Springs, NY-Stewart's Shops Corp. is recalling units of Stewart's Sportade Fruit Punch Isotonic Beverage 20 fluid oz. because they may contain undeclared milk. People who have an allergy to milk run the risk of serious or life-threatening allergic reaction if they consume this product. Approximately 1,600 units of affected product were distributed in upstate New York and Southern Vermont, and nearly 50 percent of units have already been recovered as of 4pm Wednesday.
The Sportade Fruit Punch is packaged in a 20 oz. plastic bottle, UPC 0 82086 31006 8, and has a black label with a red plastic cap. Affected units have an expiration code date of DEC 02 which can be found on the neck of the bottle. All other expiration code dates of Sportade Fruit Punch are not affected by this recall.
No illnesses have been reported to date in connection with this problem. The recall was initiated after routine quality control testing discovered that a milk allergen was in the product.
Customers who purchased Stewart's Sportade Fruit Punch with a code date of DEC 02 are urged to return them to their local Stewart's Shops for a full refund. Customers with questions may contact Stewart's Consumer Affairs Department at 518-581-1200 ext. 2130, Monday-Friday, 8am-4:30 pm.
John
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News Release
Silver Springs Farms, Inc. Recalls Beef Products Due To Possible E. Coli O157:H7 Adulteration
Class I Recall
091-2016 EXP
Health Risk: High
Oct 7, 2016
Distribution List PDF
Congressional and Public Affairs
Allie Ryan
Sarah R. Lichtman
(202) 720-9113
EDITOR’S NOTE: This release is being reissued as an expansion of the Sept. 30, 2016, release to include additional product produced from and/or commingled with the source material implicated in the original recall. The original recall included 740 pounds of ground beef products. This expansion includes an additional 7,230 pounds of ground beef patties and burgers, and 208,397 pounds of sandwich steak products. This press release was updated on Oct. 13, 2016 to include more information about the sandwich steak products, production dates and distribution area.
WASHINGTON, Oct. 7, 2016 – Silver Springs Farms, Inc., a Harleysville, Pa. establishment is recalling approximately 7,970 pounds of ground beef and burger products, and 208,397 pounds of sandwich steak products that may be adulterated with E. coli O157:H7, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
The items were produced on various dates from August 19 to Sept. 9, 2016. The following products are subject to recall:
View Labels PDF only
20-lb. cases containing 4 packages of 5-lb ground beef 80/20.
10-lb. packages of “Camellia Beef Pattie 80/20,” with package codes 20040 6235 and 20040 6242.
10-lb. packages of “Silver Springs Farm Beef Pattie 80/20,” with package codes 20040 6242 and 20030 6237.
10-lb. packages of “Silver Springs Farm Beef Pattie 80/20 Flat,” with package code 20036 6237.
10-lb. packages of “Silver Springs Farm Gourmet Beef Burger Flat,” with package code 23046 6235.
10-lb. packages of “Silver Springs Farm Gourmet Beef Burger 80/20,” with package code 23040 6237.
10-lb. packages of “Silver Springs Farm Gourmet Beef Pattie 80/20,” with package code 23040 6242.
6-lb. packages of “Allied Steak Company Beef Sandwich Slices,” with package codes EMS225 6250, EMS225 6259 and EMS444 6259.
10-lb. packages of “Anacapri Supreme Sandwich Slices,” with package codes 35000 6256, 35030 6256, 35040 6256, 35050 6256, 35060 6256, 35080 6256.
3-oz. pacakges of “Andy’s Cheesesteaks & Cheeseburgers Big Beefy Sandwich Slices,” with package code 45230H55 6244.
10-lb. pacakges of “Andy’s Cheesesteaks & Cheeseburgers Big Beefy Sandwich Slices,” with package code 45230H55 6257.
20-lb. packages of “Andy’s Cheesesteaks & Cheeseburgers Big Beefy Sandwich Slices,” with package code 45230H55 6243.
5-lb. packages of “Big Apple Deli Products Sir Chip Brand Beef Sandwich Steaks,” with package code 50500 6250.
10-lb. packages of “Big Apple Deli Products Sir Chip Brand Beef Sandwich Steaks,” with package code 50040 6250.
9-lb. packages of “Blue Diamond Beef Sandwich Steaks,” with package codes R10012 6244, R10012 6245, R10012 6250, R10012 6257, R10012 6263 and R10012 6264.
10-lb. packages of “Camellia Sir Chip Brand Beef Sandwich Steaks,” with package code 50040 6250.
10-lb. packages of “Cibao Provisions Supreme Sandwich Slices,” with package code 35060 6256.
10-lb. packages of “Flavor Peak Beef Sandwich Steaks,” with package codes 10025 6243 and 10025 6257.
5-lb. packages of “Fox’s Pizza Sir Chip Brand Beef Sandwich Steaks,” with package codes 50500 6245 and 50500 6250.
10-lb. packages of “Freedom Freedom Beef Sandwich Slices,” with package code 35050 6256.
10-lb. packages of “Hollister Meats Supreme Sandwich Slices,” with package code 35060 6257.
10-lb. packages of “Holt Beef Sandwich Slices,” with package code 35040 6252.
10-lb. packages of “Jack’s Steaks Sandwich Slices,” with package code 35060 6257.
10-lb. packages of “Keck’s Signature Supreme Sandwich Slices,” with package code 409510 6252.
10-lb. packages of “Latina Harbor Sandwich Slices,” with package code 14240 6271.
10-lb. packages of “Latina Round Rib Eye Beef Sandwich Steaks,” with package codes 82020 6242 and 82030 6242.
10-lb. packages of “Orlando Supreme Sandwich Slices,” with package code 35040 6252.
6-lb. packages of “Philly’s Best Beef Sandwich Slices,” with package code 10620 6250.
5-lb. packages of “Philly’s Best Rib Eye Beef Sandwich Steaks,” with package code 80520 6252.
5-oz. packages of “Regal Nonpareil A Reddy Raw Brand Supreme Sandwich Slices,” with package code 35050 6243.
10-lb. packages of “Regal Nonpareil A Reddy Raw Brand Supreme Sandwich Slices,” with package codes 35040 6256, 35050 6256, 35060 6256, 35080 6256
3-oz. packages of “Silver Springs Farm Beef Sandwich Steaks,” with package code 10030 6243.
5-oz. packages of “Silver Springs Farm Beef Sandwich Steaks,” with package code 10050 6243.
9-lb. packages of “Silver Springs Farm Beef Sandwich Steaks,” with package code R12122 6264.
10-lb. packages of “Silver Springs Farm Beef Sandwich Steaks,” with package codes 10020 6244, 10020 6250, 10020 6257, 10020 6263, 10020 6264, 10025 6244, 10025 6257, 10025 6265, 10030 6243, 10030 6250, 10030 6256, 10030 6259, 10030 6264, 10040 6244, 10040 6245, 10040 6266, 10050 6243 and 10050 6256.
12-lb. packages of “Silver Springs Farm Beef Sandwich Steaks,” with package codes R08242 6251, R08242 6256, R08242 6265, R08242 6266, 10000 6242, 10000 6245, 10000 6263 and 10280 6243.
40-lb. packages of “Silver Springs Farm Beef Sandwich Steaks,” with package codes 10400 6242, 10400 6250, 10400 6256 and 10400 6259.
10-lb. packages of “Silver Springs Farm Big Beefy Sandwich Slices,” with package code 45040 6252.
10-lb. packages of “Silver Springs Farm Deluxe Beef Sandwich Steaks,” with package codes 16030 6245, 16030 6258, 16040 6252, 16040 6258, 16040 6266, 16050 6245, 16050 6258, 16050 6266, 16060 6252 and 16070 6252.
10-lb. packages of “Silver Springs Farm Harbor Beef Sandwich Slices,” with package codes 14200 6271, 14240 6271 and 14250 6271.
10-lb. packages of “Silver Springs Farm Rib Eye Beef Sandwich Steaks,” with package code 80040 6245.
10-lb. packages of “Silver Springs Farm Round Rib Eye Beef Sandwich Steaks,” with package code 82020 6242.
10-lb. packages of “Silver Springs Farm Sir Chip Brand Beef Sandwich Steaks,” with package code 50040 6250.
10-lb. packages of “Silver Springs Farm Supreme Sandwich Slices,” with package codes 35000 6243, 35000 6244, 35040 6243, 35040 6252, 35040 6256, 35040 6257, 35050 6243, 35050 6244, 35050 6252, 35050 6257, 35060 6243, 35060 6244, 35060 6252 and 35060 6257.
10-lb. packages of “Smith Packing Company, Inc. Philly Style Beef Sandwich Steaks,” with package code 35020.
10-lb. packages of “Stanley Foods Inc. Beef Sandwich Steaks,” with package codes 10025 6244 and 10025 6257.
10-lb. packages of “Stanley Foods Inc. Deluxe Beef Sandwich Steaks,” with package codes 16030 6258, 16040 6245, 16040 6258 and 16050 6258.
10-lb. packages of “Supreme Pizza Supply Inc. Rib Eye Beef Sandwich Steaks,” with package code 80030 6252.
10-lb. packages of “Supreme Pizza Supply Inc. Sir Chip Brand Beef Sandwich Steaks,” with package codes 50030 6250, 50040 6250 and 50050 6250.
20-lb. packages of “The Original Big John Steak & Onion Rib Eye Beef Sandwich Steaks,” with package codes 80000BJ 6245 and 80000BJ 6252.
10-lb. packages of “The Steak ‘n Hoagie Shop Deluxe Beef Sandwich Steaks,” with package codes 16040 6245, 16040 6252, 16040 6258 and 16040 6266.
10-lb. packages of “Tubby’s Supreme Sandwich Slices,” with package code 35030 6252.
9-lb. packages of “Weis Beef Sandwich Steaks,” with package codes R04621 6242 and R04629 6264.
12-lb. packages of “Weis Beef Sandwich Steaks,” with package code R04621 6266.
The products subject to recall bear establishment number “EST. 4771” inside the USDA mark of inspection. These items were shipped to institutional and retail establishments nationwide.
The problem was discovered during a routine verification sampling performed by Silver Springs Farms, Inc. There have been no confirmed reports of illness or adverse reactions due to consumption of these products.
E. coli O157:H7 is a potentially deadly bacterium that can cause dehydration, bloody diarrhea and abdominal cramps 2–8 days (3–4 days, on average) after exposure the organism. While most people recover within a week, some develop a type of kidney failure called hemolytic uremic syndrome (HUS). This condition can occur among persons of any age but is most common in children under 5-years old and older adults. It is marked by easy bruising, pallor, and decreased urine output. Persons who experience these symptoms should seek emergency medical care immediately.
FSIS and the company are concerned that some product may be frozen and in consumers' freezers.
Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.
FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers. When available, the retail distribution list(s) will be posted on the FSIS website at www.fsis.usda.gov/recalls.
FSIS advises all consumers to safely prepare their raw meat products, including fresh and frozen, and only consume ground beef that has been cooked to a temperature of160° F. The only way to confirm that ground beef is cooked to a temperature high enough to kill harmful bacteria is to use a food thermometer that measures internal temperature, http://1.usa.gov/1cDxcDQ.
Media and consumers with questions regarding the recall can contact Dan Fillippo, Owner, Silver Springs Farms, Inc., at (215) 256-4321.
John
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https://www.niaid.nih.gov/news-events/skin-patch-treat-peanut-allergy-shows-benefit-children
Skin Patch to Treat Peanut Allergy Shows Benefit in Children
NIH-Funded Study Suggests Patch Is Safe, Convenient Mode of Treatment
October 26, 2016
A wearable patch that delivers small amounts of peanut protein through the skin shows promise for treating children and young adults with peanut allergy, with greater benefits for younger children, according to one-year results from an ongoing clinical trial (link is external). The treatment, called epicutaneous immunotherapy or EPIT, was safe and well-tolerated, and nearly all participants used the skin patch daily as directed.
The ongoing trial is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and conducted by the NIAID-funded Consortium of Food Allergy Research (CoFAR) (link is external), which is led by Hugh Sampson, M.D., of Icahn School of Medicine at Mount Sinai in New York. Stacie Jones, M.D., of the University of Arkansas for Medical Sciences and Arkansas Children’s Hospital, chairs the study. One-year outcomes are published online on October 26 in the Journal of Allergy and Clinical Immunology.
“To avoid potentially life-threatening allergic reactions, people with peanut allergy must be vigilant about the foods they eat and the environments they enter, which can be very stressful,” said NIAID Director Anthony S. Fauci, M.D. “One goal of experimental approaches such as epicutaneous immunotherapy is to reduce this burden by training the immune system to tolerate enough peanut to protect against accidental ingestion or exposure.”
CoFAR researchers at five study sites randomly assigned 74 peanut-allergic volunteers aged 4 to 25 years to treatment with either a high-dose (250 micrograms peanut protein), low-dose (100 micrograms peanut protein), or placebo patch. The investigators assessed peanut allergy at the beginning of the study with a supervised, oral food challenge with peanut-containing food. The patches were developed and provided by the biopharmaceutical company DBV Technologies under the trade name Viaskin. Each day, study participants applied a new patch to their arm or between their shoulder blades.
After one year, researchers assessed each participant’s ability to consume at least 10 times more peanut protein than he or she was able to consume before starting EPIT. The low-dose and high-dose regimens offered similar benefits, with 46 percent of the low-dose group and 48 percent of the high-dose group achieving treatment success, compared with 12 percent of the placebo group. In addition, the peanut patches induced immune responses similar to those seen with other investigational forms of immunotherapy for food allergy. Investigators observed greater treatment effects among children aged 4 to 11 years, with significantly less effect in participants aged 12 years and older.
“The clinical benefit seen in younger children highlights the promise of this innovative approach to treating peanut allergy,” said Daniel Rotrosen, M.D., director of NIAID’s Division of Allergy, Immunology and Transplantation (DAIT). “Epicutaneous immunotherapy aims to engage the immune system in the skin to train the body to tolerate small amounts of allergen, whereas other recent advances have relied on an oral route that appears difficult for approximately 10 to 15 percent of children and adults to tolerate.”
Nearly all of the study participants followed the EPIT regimen as directed. None reported serious reactions to the patch, although most experienced mild skin reactions, such as itching or rash, at the site of patch application.
“The high adherence to the daily peanut patch regimen suggests that the patch is easy-to-use, convenient and safe,” said Marshall Plaut, chief of DAIT’s Food Allergy, Atopic Dermatitis and Allergic Mechanisms Section. “The results of this study support further investigation of epicutaneous immunotherapy as a novel approach for peanut allergy treatment.”
Additional studies in larger groups of children are needed before the therapy could be approved for wider use. The CoFAR study continues to assess the long-term safety and effectiveness of peanut EPIT. After the first year, all participants began receiving high-dose daily patches, and they will continue in the study for a total of two and a half years of EPIT.
The work was funded by NIAID, NIH, under award numbers U19AI066738 and U01AI066560. Additional support was provided by NIH’s National Center for Advancing Translational Sciences. The ClinicalTrials.gov (link is external) identifier for the study Epicutaneous Immunotherapy for Peanut Allergy (CoFAR6) is NCT01904604 (link is external). The CoFAR clinical sites involved in the trial are Arkansas Children's Hospital in Little Rock, National Jewish Health in Denver, The Johns Hopkins University in Baltimore, Icahn School of Medicine at Mount Sinai in New York and the University of North Carolina at Chapel Hill School of Medicine.
Reference: SM Jones et al. Epicutaneous immunotherapy for the treatment of peanut allergy in children and young adults. Journal of Allergy and Clinical Immunology DOI: 10.1016/j.jaci.2016.08.017 (2016).
John
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News Release
Crider Inc. Recalls Canned Organic Roasted Chicken Breast Due to Possible Foreign Matter Contamination
Class I Recall
100-2016
Health Risk: High
Oct 25, 2016
Congressional and Public Affairs
Jeremy J. Emmert
(202) 720-9113
WASHINGTON, Oct. 25, 2016 – Crider Inc., a Stillmore, Ga., establishment, is recalling approximately 5,610 pounds of canned Organic Roasted Chicken Breast that may be contaminated with foreign materials the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
The cans of Wild Planet Organic Roasted Chicken Breast were produced on January 16, 2016. The following products are subject to recall:
View Label PDF only
1,496 cases of 5 ounce cans of “Wild Planet Organic Roasted Chicken Breast – 100% Chicken Breast & Sea Salt – No Liquids Added” with a Best Buy Date of 01/16/18
The products subject to recall bear establishment number “EST. 31812” inside the USDA mark of inspection. These items were shipped to multiple distributers for further distribution.
The problem was discovered when a distributer received two complaints from consumers involving foreign matter in the product on October 2, 2016 and October 9, 2016.
The company received a report of a potential injury associated with consumption of this product. FSIS has received no additional reports of injury or illness from consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider.
Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.
FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers. When available, the retail distribution list(s) will be posted on the FSIS website at www.fsis.usda.gov/recalls.
Media with questions about the recall can contact Mark Howell, Vice President of Sales, at (912) 562-9276. Customer with questions about the recall can contact Judy Tridico, Customer Service representative at (912) 562-9162
John
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Public Notification: Zi Su Body Fat Health II (紫苏瘦身营养素 II – Zi Su Shou Shen Ying Yang Su II) Contains Hidden Drug Ingredient
10-19-2016
The Food and Drug Administration (FDA) is advising consumers not to purchase or use Zi Su Body Fat Health II, a product promoted for weight loss. This product was identified by FDA during an examination of international mail shipments.
FDA laboratory analysis confirmed that Zi Su Body Fat Health II contains sibutramine and phenolphthalein.
Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons. The product poses a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. This product may also interact, in life-threatening ways, with other medications a consumer may be taking.
Phenolphthalein is a chemical that is not an active ingredient in any approved drug in the United States. Studies have indicated that it presents a cancer-causing risk.
Health care professionals and patients are encouraged to report adverse events or side effects related to the use of this product to FDA's MedWatch Safety Information and Adverse Event Reporting Program:
https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home
Complete and submit the report online MedWatch Online Voluntary Reporting Form, or:
Download and complete the form,
http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM349464.pdf
then submit it via fax at 1-800-FDA-0178.
Note: This notification is to inform the public of a growing trend of dietary supplements or conventional foods with hidden drugs and chemicals. These products are typically promoted for sexual enhancement, weight loss, and body building and are often represented as being “all natural.” FDA is unable to test and identify all products marketed as dietary supplements that have potentially harmful hidden ingredients. Consumers should exercise caution before purchasing any product in the above categories.
For more information:
Tainted Weight Loss Product
Subscribe to the RSS feed
Beware of Fraudulent ‘Dietary Supplements’
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm246744.htm
Contact FDA
Toll Free
(855) 543-3784, or
(301) 796-3400
Human Drug Information
Division of Drug Information (CDER) http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm082585
Office of Communications
Feedback Form
http://www.accessdata.fda.gov/scripts/email/cder/comment.cfm
10001 New Hampshire Avenue
Hillandale Building, 4th Floor
Silver Spring, MD 20993
John
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St. Jude Medical Recalls Implantable Cardioverter Defibrillators (ICD) and Cardiac Resynchronization Therapy Defibrillators (CRT-D) Due to Premature Battery Depletion
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Recalled Product(s):
Fortify, Unify, and Assura Implantable Cardioverter Defibrillators (ICD) and Cardiac Resynchronization Therapy Defibrillators (CRT-D)
Model/Item Numbers: See “Full List of Affected Devices”
Manufacturing Dates: January 2010 to May 2015
Distribution Dates: February 2010 to October 2016
Devices Recalled in the U.S.: 251,346 Nationwide
Device Use
St. Jude Medical Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are devices that provide pacing for slow heart rhythms, and electrical shock or pacing to stop dangerously fast heart rhythms.
ICDs and CRT-Ds are both implanted under the skin in the upper chest area with connecting insulated wires called “leads” that go into the heart. Patients need an ICD or CRT-D if their heart beat is too slow (bradycardia), too fast (tachycardia), or needs coordination to treat heart failure.
Reason for Recall
St. Jude Medical is recalling certain models of the Fortify, Unify, and Assura ICDs and CRT-Ds due to reports of rapid battery failure caused by deposits of lithium (known as “lithium clusters”), forming within the battery, and causing a short circuit.
If the battery unexpectedly runs out before the patient is aware of the rapid battery drain and able to have it replaced, the ICD or CRT-D will be unable to deliver life-saving pacing or shocks, which could lead to patient death.
Who May be Affected
Patients with a St. Jude Medical ICD or CRT-D device
Caregivers of patients with a St. Jude Medical ICD or CRT-D device
Health care providers treating patients with heart failure or heart rhythm problems using St. Jude Medical ICD or CRT-D devices
What to Do
On October 10, 2016, St. Jude Medical sent notification letters to customers and health care providers informing them of the possibility of premature battery depletion in affected ICD and CRT-D devices.
Additionally, on October 11, 2016, the FDA issued a safety communication regarding this recall,
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm524666.htm and provided recommendations for health care providers, patients, and caregivers.
Full List of Affected Devices:
Fortify VR: Model No(s). CD1231-40, CD1231-40Q
Fortify ST VR: Model No(s). CD1241-40, CD1241-40Q
Fortify Assura VR: Model No(s). CD1257-40, CD1257-40Q, CD1357-40C, CD1357-40Q
Fortify Assura ST VR: Model No(s). CD1263-40, CD1263-40Q, CD1363-40C, CD1363-40Q
Fortify DR: Model No(s). CD2231-40, CD2231-40Q.
Fortify ST DR: Model No(s). CD2241-40, CD-2241-40Q, CD2263-40, CD2263-40Q
Fortify Assura DR: Model No(s). CD2257-40, CD2257-40Q, CD2357-40C, CD2357-40Q
Fortify Assura ST DR: Model No(s). CD2363-40C, CD2363-40Q
Unify: Model No(s). CD3231-40, CD3231-40Q
Unify Quadra: Model No(s). CD3249-40, CD3249-40Q
Unify Assura: Model No(s). CD3257-40, CD3257-40Q, CD3357-40C, CD3357-40Q
Quadra Assura: Model No(s). CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q
Quadra Assura MP: Model No(s). CD3269-40, CD3269-40Q, CD3369-40C
Contact Information
Customers with questions may contact St. Jude Medical Customer Service at: 1-866-915-5065.
Date Recall Initiated
October 10, 2016
Additional Resources:
St. Jude Medical – Premature Battery Depletion Information
I cannot get this link to work
St. Jude Medical – Battery Advisory
I cannot get this link to work
Premature Battery Depletion of St. Jude Medical ICD and CRT-D Devices: FDA Safety Communication
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm524666.htm
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program. Health care professionals employed by facilities that are subject to FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.
John
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HeartWare Recalls Ventricular Assist Device Pumps Due to Contamination Causing Electrical Issues
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Recalled Product:
HeartWare Ventricular Assist Device (HVAD)
Serial Numbers: All HVADs with serial numbers lower than HW25838
Product Codes: 1103, 1104
Manufacturing Dates: March 17, 2006 to June 27, 2016
Devices Recalled in the U.S.:105 units distributed nationwide
Device Use
The HVAD helps deliver blood from the heart to the rest of the body. It is used in patients who are at risk of death from end-stage left ventricular heart failure and who are waiting for a heart transplant. The system includes a pump implanted in the space around the heart (pericardium) and a controller that controls the speed and function of the pump.
The HVAD is designed for use both in and out of hospital settings, including during patient transport.
Reason for Recall
HeartWare Inc. is recalling the HVAD pumps due to a design problem with the driveline connector. The driveline is a tube that connects the HVAD's pump to the external controller and power source. Contamination of the driveline may result in fluid or other material entering the pump and causing electrical issues or pump stops that may lead to serious adverse health consequences, including death.
Who May be Affected
Patients receiving cardiac support using the HVAD system
Health care providers and caregivers monitoring patients with a HVAD system
What to Do
On August 17, 2016, HeartWare Inc. sent an "Urgent Medical Device Recall Letter" to affected customers. The letter instructed consumers to:
Identify affected HVADs in hospital inventory
Complete and return the "Acknowledgement Form" attached to the letter
Return affected products to HeartWare Inc.
After returning the affected products, complete and return the "Completion Form" to a HeartWare representative no later than 2 months from the date on the letter
Remind their patients about the safe use of the HVAD System, particularly with regard to moisture and proper connection to power and data sources.
Contact Information
Health care providers who have questions should contact their HeartWare representative or contact HeartWare Inc. at cs@heartware.com or 1-877-367-4823 with any questions related to this recall.
Date Recall Initiated:
July 29, 2016
Additional Resources:
Firm Press Release
http://ir.heartware.com/phoenix.zhtml?c=187755&p=irol-newsArticle_Print&ID=2207145
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home
either online, by regular mail or by FAX to 1-800-FDA-0178.
John
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News Release
St. Clair Foods, Inc. Recalls Poultry Products Due To Misbranding And An Undeclared Allergen
Class I Recall
099-2016
Health Risk: High
Oct 21, 2016
Congressional and Public Affairs
Benjamin Bell
(202) 720-9113
WASHINGTON, Oct. 21, 2016 – St. Clair Foods, Inc., a Memphis, Tenn. establishment, is recalling approximately 26,800 pounds of chicken and dumplings due to misbranding and an undeclared allergen, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The products contain milk, a known allergen, which was not declared on the product label.
The chicken and dumplings were produced on various dates from Sept. 13 through Oct. 6, 2016. The following products are subject to recall:
View Labels PDF Only
5-lb. Plastic sealed packages containing “ST. CLAIR FOODS CHICKEN AND DUMPLINGS” bearing package codes 16257, 16264, and 16280.
2-lb. Plastic sealed packages containing “ST. CLAIR FOODS CHICKEN AND DUMPLINGS” bearing package codes 16257, 16264, and 16280.
5-lb. Plastic sealed packages containing “RON’S HOMESTYLE FOODS CHICKEN AND DUMPLINGS” bearing package codes 16280, 16272, 16264, and 16257.
The products subject to recall bear establishment number “EST-6568” inside the USDA mark of inspection. These items were shipped to food service warehouses and distributed for institutional use in Alabama, Arkansas, Kentucky, Mississippi, Tennessee, and Texas.
The problem was discovered by the establishment on October 20, 2016 during a review of product specifications. The establishment was not notified by their ingredient supplier that there was a change in the dumpling ingredients to include the addition of the milk ingredient. The establishment immediately notified FSIS that the undeclared milk allergen ingredient was incorporated into their products.
There have been no confirmed reports of injury, illness, or adverse reactions due to consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider.
Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.
FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers. When available, the retail distribution list(s) will be posted on the FSIS website at www.fsis.usda.gov/recalls.
Consumers with questions about the recall can contact Monica Woodruff at (901) 322-7301. Media with questions about the recall can contact Brian Edmonds at (901) 322-7328.
John
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News Release
Brookwood Farms, Inc. Recalls Pulled Pork Products Due To Misbranding And An Undeclared Allergen
Class II Recall
098-2016
Health Risk: Low
Oct 21, 2016
Congressional and Public Affairs
Julie Schwartz
(202) 720-9113
WASHINGTON, Oct. 21, 2016 – Brookwood Farms, Inc., a Siler City, N.C. establishment, is recalling approximately 126,570 pounds of pulled pork products due to misbranding and undeclared allergens, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The product contains soy, a known allergen which is not declared on the product label.
The fully cooked, pulled pork items were produced between June 12, 2014 and Oct. 21, 2016. The following products are subject to recall:
View Label
5-lb. plastic bags containing “COOKED PULLED PORK CARNITA STYLE.”
The products subject to recall bear establishment number “EST. 1740” inside the USDA mark of inspection and code 15006 on the label. These items were distributed for institutional use nationwide.
The problem was discovered by FSIS inspection personnel while conducting routine label verification activities.
There have been no confirmed reports of injury, illness, or adverse reactions due to consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider.
Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.
FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers.
Consumers with questions about the recall can contact Craig Wood, Vice President, at (919) 663-3612 ext.226. Media with questions about the recall can contact Twig Wood, President, at (919) 663-3612 ext.224.
John
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Company Announcement
When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.
Brownwood Farms Issues Allergy Alert On Undeclared Milk In Fruit Preserves And Fruit Butter Products
For Immediate Release
October 20, 2016
Contact
Consumers
Brownwood Farms
1-888-772-9444
Announcement
View Product Photos
Williamsburg, MI - Brownwood Farms is recalling approximately 260,000 total units of the listed products, because they contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction, if they consume these products.
The affected products were distributed across the United States through distributors, retailers and on-line sales from the Brownwood Farms website.
All products listed below with the referenced “Best by” dates are included in this recall. “Best by” dates are indicated on labels affixed to the bottom of all affected products. The affected products are all packaged in glass containers with metal lids.
BROWNWOOD FARMS ISSUES ALLERGY ALERT ON UNDECLARED MILK IN THE FOLLOWING PRODUCTS:
AMERICA’S ORIGINAL CHERRY BUTTER 12 oz. – UPC 018303-005011- with best by dates before 09/28/2018
AMERICA’S ORIGINAL CHERRY BUTTER 22oz. – UPC 018303-005301- with best by dates before 09/28/2018
AMERICA’S ORIGINAL CHERRY BUTTER – 1 Gallon - with best by dates before 09/28/2018
CHERRY RASPBERRY PRESERVES 12 oz. – UPC 018303-005035 - with best by dates before 09/28/2018
CHERRY RASPBERRY PRESERVES – 1 Gallon - with best by dates before 09/28/2018
MICHIGAN CHERRY PRESERVES 12 oz. – UPC 018303-005028 - with best by dates before 09/28/2018
MICHIGAN CHERRY PRESERVES – 1 Gallon - with best by dates before 09/28/2018
PEAR AND CINNAMON PRESERVES 10 oz. – UPC 018303-005172 - with best by dates before 09/28/2018
PEAR AND CINNAMON PRESERVES - 1 Gallon - with best by dates before 09/28/2018
STRAWBERRY PRESERVES 12 oz. – UPC 018303-005059 - with best by dates before 09/28/2018
STRAWBERRY PRESERVES - 1 Gallon - with best by dates before 09/28/2018
JALAPENO CHERRY BUTTER – 12 oz. – UPC 018303 – 005134 - with best by dates before 09/28/2018
JALAPENO CHERRY BUTTER – 20 oz. – UPC 018303 – 005325 - with best by dates before 09/28/2018
JALAPENO CHERRY BUTTER – 1 Gallon – with best by dates before 09/28/2018
No illnesses have been reported to date.
The recall was initiated after an employee discovered that ingredients used in the production of the affected products contained milk, in the form of butter, and the packaged product did not have labels indicating the presence of milk.
Consumers who have the product in your possession are urged to return it to their retailer for a full refund. Consumers with questions may contact the company Monday through Friday at 1-888-772-9444 between the hours of 9:00 AM and 5:00 PM (Eastern) or via email at recall@brownwoodfarms.com.
John
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https://www.cpsc.gov/Recalls/2017/Target-Recalls-Halloween-LED-Gel-Clings
Target Recalls Halloween LED Gel Clings Due to Choking and Button Battery Ingestion Hazards
Recall date: October 20, 2016
Recall number: 17-020
Recall Summary
Name of product: LED gel clings
Hazard: The gel clings can separate and expose the inner decal and LED/button battery compartment, posing choking and button battery ingestion hazards to children.
Consumer Contact:
Target at 800-440-0680 from 7 a.m. to 8 p.m. CT Monday through Sunday, online at www.Target.com and click on “School/Stationery/Seasonal” on the product recalls page for more information, or the “Product Recalls” tab on Target’s Facebook page.
Recall Details
Units:
About 127,000
Description:
This recall involves six different Halloween-themed LED gel clings that come with two non-replaceable button cell batteries. The gel clings are for window use only and light up with a blinking light when you push on them. The six different gel cling designs are a green skeleton, pink skeleton, purple spider, black cat, orange pumpkin, and black bat. Model number 234-25-0904 is printed on the gel cling’s packaging.
Product
Model Number
Color/Description
Size
LED Gel Cling
234-25-0904
Green Skeleton
3”(L) x 2”(W) x .5”(H)
Pink Skeleton
3”(L) x 2”(W) x .5”(H)
Purple Spider
2”(L) x 4”(W) x .5”(H)
Purple and Black Cat
2”(L) x 2.75”(W) x .5”(H)
Orange and Black Pumpkin
2.75”(L) x 2.5(W) x .5”(H)
Green and Black Bat
2” (L) x 4”(W) x .5”(H)
Incidents/Injuries:
None reported
Remedy:
Consumers should immediately remove the recalled gel clings from areas with children and return them to any Target store for a full refund.
Sold Exclusively At:
Target stores nationwide from August 2016 through September 2016 for about $1.
Importer(s):
Target Corp., of Minneapolis, Minn.
Manufactured In:
China
John
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https://www.cpsc.gov/Recalls/2017/Makita-Recalls-Circular-Saws
Makita Recalls Circular Saws Due to Laceration Hazard
Recall date: October 20, 2016
Recall number: 17-019
Recall Summary
Name of product: Circular saws
Hazard: The lower blade guard can malfunction and expose the blade, posing a laceration hazard and risk of injury to the consumer.
Consumer Contact:
Makita U.S.A. at 800-462-5482 from 8 a.m. to 7:45 p.m. ET Monday through Friday or online at www.makitatools.com for more information.
Recall Details
Units:
About 450
Description:
This recall involves the Makita 5057KB 7-1/4” circular saw with dust collector. The model number and serial number are located on the black nameplate under the name “Makita.” The saw’s housing is a blue-green color and “Makita” is printed on the dust cover. The serial number ranges included in this recall are: 12638-12737, 12978-13027, 13208-13257, 133322-13351, 13376-134505, 13578-13627, 13568-13707 and 13900-13979.
Incidents/Injuries:
None reported
Remedy:
Consumers should immediately stop using the recalled circular saws and contact Makita to schedule a free repair.
Sold At:
Tools Plus and other industrial suppliers nationwide and various websites including www.Amazon.com from March 2016 through September 2016 for about $400.
Importer(s):
Makita U.S.A. Inc., of La Mirada, Calif.
Distributor(s):
Makita U.S.A. Inc., of La Mirada, Calif.
Manufactured In:
Japan
John
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https://www.cpsc.gov/Recalls/2017/Cabelas-Recalls-Food-Dehydrators
Cabela’s Recalls Food Dehydrators Due to Fire Hazard
Recall date: October 20, 2016
Recall number: 17-018
Recall Summary
Name of product: Cabela’s food dehydrators
Hazard: Defective wiring can cause a build-up of heat, posing a fire hazard.
Consumer Contact:
Cabela’s at 800-237-4444 anytime, or online at www.cabelas.com for more information.
Recall Details Report an Incident Involving this Product
Units:
About 3,000
Description:
This recall involves Cabela’s commercial grade 80-liter and 160-liter food dehydrators. The stainless steel dehydrators have model numbers 541549 on the 80 liter, and 541650 on the 160 liters. Model numbers are located on the back panel of the dehydrator.
Incidents/Injuries:
The firm has received nine reports of the product malfunctioning due to defective wiring. No injuries have been reported.
Remedy:
Consumers should immediately stop using the recalled dehydrators and contact Cabela’s to receive a replacement product or a refund.
Sold At:
Cabela’s stores nationwide and online at Cabelas.com from August 2016 through September 2016 for about $300 for the 80-liter model and $415 for the 160-liter model.
Importer(s):
Cabela’s Inc., of Sidney, Neb.
Distributor(s):
Cabela’s Inc., of Sidney, Neb.
Manufactured In:
China
John
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News Release
Michigan Turkey Producers Recalls Turkey Products Due To Possible Foreign Matter Contamination
Class I Recall
097-2016
Health Risk: High
Oct 15, 2016
Distribution List PDF
Congressional and Public Affairs
Autumn Canaday
(202) 720-9113
WASHINGTON, Oct. 15, 2016 – Michigan Turkey Producers, a Grand Rapids, Mich. establishment, is recalling approximately 54,011 pounds of turkey breast products that may be contaminated with extraneous materials, specifically an unidentified black material, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
The oven roasted turkey breast items (logs and sliced) were produced on August 29, 2016 and September 16, 2016. The following products are subject to recall:
View Labels PDF Only
12-lb. packages containing “MESON SANDWICHES, OVEN ROASTED SLICED TURKEY BREAST” with a use or freeze by date of 11/27/16, and a case code of “48598” on the left side of the label
22-lb. logs containing “OVEN ROASTED TURKEY BREAST WITH BROTH,” with a use or freeze by date of 11/27/16, and a case code of “48576” on the left side of the label
22-lb. logs containing “OVEN ROASTED TURKEY BREAST WITH BROTH,” with a use or freeze by date of 12/15/16, and a case code of “48576” on the left side of the label
The products subject to recall bear establishment number “P-20935A” inside the USDA mark of inspection. These items were shipped to a distribution center in Florida and food services in Florida and Puerto Rico.
The problem was discovered when the establishment received a customer complaint.
FSIS has received no confirmed reports of injury or illness from consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider.
Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.
FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers. When available, the retail distribution list(s) will be posted on the FSIS website at www.fsis.usda.gov/recalls.
Consumers with questions about the recall can contact Deborah Hein, director of quality assurance, at (616) 245-2221, ext. 237. Media with questions about the recall can contact Dan Lennon, president, at (616) 475-4183.
John
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Willy Rusch Tracheostomy Tube Set by TeleFlex Medical: Class I Recall - Possible Disconnection During Patient Use
Posted 10/20/2016
AUDIENCE: Risk Manager, Surgery
ISSUE: Teleflex is recalling the Willy Rusch Tracheostomy Tube Set due to the possibility that the connector may disconnect from the tracheostomy tube during use on a ventilated patient. If the connector detaches from the tracheostomy tube shaft during use, it can deprive the patient of adequate ventilation and would require immediate medical intervention including changing the tracheostomy tube and placing a new tube. The use of affected products may cause serious adverse health consequences including oxygen deprivation, brain damage and death.
Lot Numbers: 15451, 15291, 15331, 15371, 15501, 15261, 15391, 15421, 15461, 15491
Product Codes: 120502-000030, 120502-000040, 120502-000050, 120502-000060, 858121-000050, 858121-000060
Manufacturing Dates: June, 2015 to December, 2015
Distribution Dates: July, 2015 to May, 2016
BACKGROUND: A tracheostomy tube is a single-use device that is placed through the patient’s windpipe (trachea) during a surgical procedure called a tracheostomy to create safe airway access and provide a pathway to remove fluid from the trachea and lungs.
RECOMMENDATION: On August 26, 2016, Teleflex Medical sent an "Urgent Field Safety Notice" to all affected customers. The notice asked customers to:
Identify and quarantine any affected devices in your inventory.
Complete and return the Acknowledgement Form.
Mark the according checkbox on the form to indicate if your facility has an affected device.
After completing the form, contact customer service by calling 866-246-6990, who will issue you a return number. Be sure to write this number into the respective field in the Acknowledgement form.
Complete and return "Appendix 1" of the form for all products in your possession and under control, and fax it to 1-855-419-8507, or provide a completed copy to your local Sales Representative.
Teleflex (or your local dealer) will issue a credit note upon receipt of the returned affected product.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
Complete and submit the report Online: www.fda.gov/MedWatch/report
Download form
http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm
or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[10/20/2016 - Recall Notice - FDA]
http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm526022.htm
John
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https://www.cpsc.gov/Recalls/2017/Husqvarna-Recalls-Lawn-Mowers
Husqvarna Recalls Lawn Mowers Due to Laceration Hazard
Recall date: October 18, 2016
Recall number: 17-009
Recall Summary
Name of product: Lawn mowers
Hazard: The operator presence control bar can malfunction and cause the engine and blades to continue to operate when they should shut off, posing a laceration hazard to the operator.
Consumer Contact:
Call Husqvarna toll-free at 877-257-6921 from 8 a.m. to 6 p.m. ET Monday through Friday, email at recalls@husqvarna.com or online at http://husqvarna.custhelp.com/app/answers/detail/a_id/1255/ for more information
Recall Details
In Conjunction With:
Canadian Flag
Units:
About 235,000 (27,000 of which were sold in Canada)
Description:
This recall involves Husqvarna®, Poulan Pro®, Jonsered®, Craftsman®, Yardworks®, Murray®, and Brute® brand walk-behind gas powered lawn mowers with Briggs & Stratton 7.25 HP engines. They were sold in red, orange, blue and yellow/black colors and have either four similar-sized wheels or two larger rear wheels and two smaller front wheels, a long handle with an operator presence control bar that is pushed down towards the mower handle to start the engine, a mowing deck, and may have come with or without a collecting bag in the rear. The brand names are printed on the mowers, and a Briggs & Stratton logo is printed on the engine shield. The mower model and serial number can be found on the rear of the mowing deck, next to the rear wheel. The following model and serial numbers are included in the recall.
Brand
Model Name
Serial Number Range
Brute
961480058
110115M00001 - 082516M50000
Craftsman
10176
10178
37275
37489
110115M00001 - 082516M50000
Husqvarna
LB155S
LC121P
HU725AWDEX
HU725AWDH
HU725AWDHQ
110115M00001 - 082516M50000
Jonsered
LM 2153CMDA
LM 2155MD
LM 2153CMDA
110115M00001 - 082516M50000
Murray
21P68H30
110115M00001 - 082516M50000
Poulan Pro
961320100
961420133
PR675Y22RHPE
PR725Y22RHP
961490006
110115M00001 - 082516M50000
Yardworks
961380047
961480057
110115M00001 - 082516M50000
Incidents/Injuries:
The firm has received 53 reports of the engine not shutting off after the operator presence control bar was released. No injuries have been reported.
Remedy:
Consumers should immediately stop using the recalled lawn mowers and contact Husqvarna or go to http://husqvarna.custhelp.com/app/answers/detail/a_id/1255/ to determine if their unit needs a free repair.
Sold At:
Lowe’s, Sears and other hardware stores, home centers and equipment dealers nationwide from November 2015 through August 2016 for between $250 and $450.
Manufacturer(s):
Husqvarna Consumer Outdoor Products N.A. Inc., of Charlotte, N.C.
Manufactured In:
U.S.
John
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https://www.cpsc.gov/Recalls/2017/TUSA-Recalls-Diving-Computers
TUSA Recalls Diving Computers Due to Drowning and Injury Hazards
Recall date: October 18, 2016
Recall number: 17-016
Recall Summary
Name of product: Diving computers
Hazard: The dive computer can malfunction and display an incorrect reading to the diver, posing a drowning and injury hazard due to decompression sickness.
Consumer Contact:
TUSA at 800-482-2282 from 8 a.m. to 5 p.m. PT Monday through Friday or online at http://www.tusa.com/recall.pdf for more information.
Recall Details
Units:
About 175
Description:
This recall involves TUSA DC Solar Link IQ1204 diving computers. The black or white and blue wrist-watch style diving computers have a digital screen. TUSA is printed on the front of the diving computer. The model number and serial number is printed on the back of the diving computer below “TUSA DC Solar Link.” Recalled diving computers have serial numbers 6TA0001 – 6TA2864.
Incidents/Injuries:
None reported
Remedy:
Consumers should immediately stop using the recalled diving computers and contact TUSA to receive a free replacement diving computer.
Sold At:
Sporting goods stores nationwide from March 2016 through June 2016 for about $750.
Importer(s):
Tabata USA Inc. (TUSA), of Long Beach, Calif.
Distributor(s):
Tabata USA Inc. (TUSA), of Long Beach, Calif.
Manufactured In:
Japan
John
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https://www.cpsc.gov/Recalls/2017/Sherwood-Marketing-Recalls-3-Squares-Rice-and-Slow-Cookers
Sherwood Marketing Recalls 3 Squares Rice and Slow Cookers Due to Fire, Electric Shock Hazards
Recall date: October 18, 2016
Recall number: 17-017
Recall Summary
Name of product: 3 Squares rice and slow cookers
Hazard: The rice/slow cooker’s improperly installed wiring can cause electrical shorting in the unit, posing fire and electric shock hazards.
Consumer Contact:
3 Squares at 800-390-0249 from 9 a.m. to 5 p.m. PT Monday through Friday or online at www.Get3Squares.com and click on Recall for more information.
Recall Details
In Conjunction With:
Canadian Flag
Units:
About 175,000 (in addition, 100 were sold in Canada)
Description:
This recall involves 3 Squares-branded Tim3 Machin3 and Mini Tim3 Machin3 rice and slow cookers with fixed power cords. The 20-cup/4-quart or 8-cup/1.7-quart programmable electric cookers are stainless steel with black molded plastic, have a control panel/keypad on the front and measure about 11 inches in diameter and12 inches tall. The 3Squares logo is printed on the front of the control panel. Model numbers starting with 3RC and ending in 3010S, 3020S, 3434, 5020 and 9010S are included in the recall. The model number is printed on a label on the side of the product.
Incidents/Injuries:
The firm has received three incident reports, including a cooker sparking when turned on and a cooker turning itself on. One shock injury was reported.
Remedy:
Consumers should immediately stop using the recalled rice/slow cookers and contact 3 Squares to receive a free replacement cooker, including shipping.
Sold At:
Home, hardware, mass merchandisers and department stores nationwide and online at Amazon, Bed Bath & Beyond, Best Buy, Costco, Get3Squares, Home Depot, Kohl’s, Target, Wayfair and other websites from December 2015 through July 2016 for between $30 and $70, depending on the model and capacity.
Importer(s):
Sherwood Marketing, owner of the 3 Squares brand, LLC, of San Diego, Calif.
Distributor(s):
Sherwood Marketing, owner of the 3 Squares brand, LLC, of San Diego, Calif.
Manufactured In:
China
John
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I take it as an insult.
John
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Tuesday, October 18, 2016
Women report vaginal ring for preventing HIV had little effect on sexual intercourse
Most women who used an experimental vaginal ring for HIV prevention report that the physical act of sex was largely unaffected by using the product, which is inserted monthly for continuous wear. This finding is among several insights gleaned about experiences of women who used the ring during the ASPIRE study, also known as MTN-020, announced today at the HIV Research for Prevention (HIVR4P) meeting (link is external) in Chicago.
ASPIRE evaluated whether the ring, which continuously releases the anti-HIV drug dapivirine, could safely reduce HIV infection among 2,629 women aged 18-45 years living in Malawi, South Africa, Uganda and Zimbabwe. Among participants randomized to receive the dapivirine ring, risk of HIV infection fell by 27 percent. A further analysis found that the ring reduced the risk of HIV infection by at least 56 percent among women who used it with greater frequency, and up to 75 percent or higher among those who used it consistently. Further exploration of the ring’s clinical potential began in July 2016 through the large-scale HOPE (HIV Open-Label Prevention Extension) study, also known as MTN-025. ASPIRE, HOPE and their ancillary studies were primarily funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). The nonprofit International Partnership for Microbicides developed the dapivirine ring and supplied it for the studies.
“Women need an HIV prevention modality that offers safe, effective protection and is practical for use in their daily lives,” said NIAID Director Anthony S. Fauci, M.D. “Women enrolled in the MTN-020/ASPIRE study reported that the experimental vaginal ring generally did not interfere with sexual intercourse, which is an encouraging sign that this product could appeal to a larger group of women at risk for HIV infection.”
The ASPIRE study staff interviewed 214 participants who used the ring to obtain qualitative data about their sexual experiences during the trial. A team led by Nicole Laborde, Ph.D., M.P.H., of RTI International in Research Triangle Park in North Carolina, analyzed the participant responses. While most of these women found that the ring did not negatively affect the physical act of sex, some women said they were continually preoccupied with how their partners would react if they felt or discovered the ring. To address this issue, some women removed the ring before sex, a practice not recommended by study investigators. Other women limited sexual activities that they believed might heighten their partners’ awareness of the ring, such as certain sexual positions and receptive oral or digital sex.
Some women reported greater sexual satisfaction partially due to perceived protection provided by the ring. Other women reported diminished sexual pleasure associated with the worry that their male partners would notice the ring during sex.
Additional analyses of the ASPIRE data revealed other patterns of experience among study participants. Because women who face intimate partner violence and other social harms more often find it difficult to adhere to the clinically proven once-daily antiretroviral drug Truvada as pre-exposure prophylaxis, or PrEP, researchers investigated the connection between consistent use of the ring and these issues. While fewer than 5 percent of all ASPIRE study participants reported incidents of intimate partner-related violence or other social harms, women who did report violence or social harm within a month of the interview were nearly 2.5 times more likely to have low adherence to the ring. Younger age at enrollment, having a new primary partner and not disclosing study participation or ring use to the primary partner were significantly associated with reporting social harms. These findings, reported by a team led by Thesla Palanee-Phillips, M.Med.Sci, Ph.D., M.Sc., at the Wits Reproductive Health and HIV Institute in Johannesburg, South Africa, indicate that more research is needed to determine strategies to mitigate low adherence in the context of intimate partner violence and other social harms in future studies of female-controlled prevention methods.
The potential for women to suffer social harm and violence by sexual partners, along with other qualitative data from HIV prevention studies, suggest that some women may prefer methods of HIV protection undetectable by sexual partners. Additional new data revealed that a majority of women—64 percent—disclosed the use of the ring to their male partners at the outset of the study, while 13 percent of study participants never revealed that they were using the ring. The investigators, led by Lulu Nair, M.B.Ch.B., M.P.H., of the Desmond Tutu HIV Centre at the University of Cape Town, found that neither disclosing nor concealing use of the ring affected women’s adherence to the product.
“Sub-Saharan African women have a broad range of sexual experiences and relationship dynamics, and we are learning more about how these diverse behaviors and circumstances influence the use of the ring,” said Dr. Palanee-Phillips, director of Network trials at the Wits Reproductive Health and HIV Institute in Johannesburg, South Africa and protocol co-chair on the ASPIRE study. “While we have found that most women do disclose ring use to their primary partners, it is reassuring that adherence is not affected for the significant minority of women who choose to use it more discreetly.”
Researchers led by Ariane van der Straten, Ph.D., M.P.H., of RTI International also found that women’s concerns about using an experimental vaginal ring for HIV prevention decreased significantly over the course of the study. At clinical visits, women were asked, “How worried are you about having a vaginal ring inside you every day for at least a year?” While 29 percent of women reported this concern at the start of the study, only 4 percent of participants did so at their final follow-up clinic visit. Specific concerns related to use, health, hygiene, sexual enjoyment and social approval also decreased significantly between the start and the end of the study.
As research on the ring continues in the HOPE study, investigators will collect both quantitative and qualitative data from women at risk for HIV infection. All participants in HOPE will receive access to a package of HIV prevention services, including condoms, partner testing and counseling, and will be able to stay in the study regardless of whether or not they choose to accept the ring after their initial clinic visit. The study investigators believe this approach will shed light on the critical questions of whether participants like using the ring, and why.
The ASPIRE study was funded by NIAID, the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institute of Mental Health, all part of NIH, and conducted by the NIH-funded Microbicide Trials Network (link is external). For more information about the dapivirine ring, visit www.IPMglobal.org (link is external). Learn more about ASPIRE by visiting ClinicalTrials.gov using study identifier NCT01617096 or about HOPE by using study identifier NCT02858037.
NIAID conducts and supports research—at NIH, throughout the United States, and worldwide—to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID website.
About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.
John
Recall: Frozen Strawberries
in Pinching Pennies
Posted
http://www.fda.gov/Safety/Recalls/ucm527273.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery
Company Announcement
When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.
ICAPP Voluntarily Recalls Certain Lots of Frozen Strawberries
For Immediate Release
October 30, 2016
Contact
Consumers
ICAPP
customerservice@icapp.com.eg
+201-541-1624
Announcement
The International Company for Agricultural Production & Processing (ICAPP) is voluntarily recalling certain lots of its frozen strawberries out of an abundance of caution in response to a U.S. Food and Drug Administration (FDA) investigation of an outbreak of Hepatitis A. For more information about this investigation, please visit FDA’s outbreak investigation website at http://www.fda.gov/Food/RecallsOutbreaksEmergencies/Outbreaks/ucm518775.htm.
The recalled products were all distributed for sale to and use in food service establishments nationwide -- not for use in food products offered for retail sale to consumers. Nonetheless, ICAPP is issuing this news release publicly to help mitigate any possible risk to the public health and to fully ensure that all recalled products are recovered. Although none of ICAPP’s own testing through an established surveillance program or through third party testing of retained samples has identified the presence of Hepatitis A in any of its products, ICAPP has decided to recall all frozen strawberries that it has imported into the United States since January 1, 2016 out of an abundance of caution.
No other ICAPP products, frozen or fresh, are covered by this voluntary recall.
ICAPP is conducting this voluntary recall after learning that frozen strawberries that it distributed may be linked to a recent Hepatitis A outbreak in the United States. ICAPP has been engaged with FDA in its investigation of this outbreak and is taking this action in consultation with FDA because Hepatitis A virus was detected in four lots of frozen strawberries that were exported to the U.S. by ICAPP. ICAPP is working closely with all of the U.S. distributors of this product to ensure that this recall is effective.
Hepatitis A is a contagious liver disease that results from exposure to the Hepatitis A virus, including from food. It can range from a mild illness lasting a few weeks to a serious illness lasting several months. Illness generally occurs within 15 to 50 days of exposure and includes fatigue, abdominal pain, jaundice, abnormal liver tests, dark urine and pale stool. Hepatitis A vaccination can prevent illness if given within two weeks of exposure to a contaminated food. In rare cases, particularly consumers who have a pre-existing severe illness or are immune compromised, Hepatitis A infection can progress to liver failure. Persons who may have consumed affected product should consult with their health care professional or local health department to determine if a vaccination is appropriate, and consumers with symptoms of Hepatitis A should contact their health care professionals or the local health department immediately.
ICAPP is fully committed to producing safe and high quality products; consumer safety is its top priority. ICAPP is conducting a comprehensive review of all of its operations and its suppliers to ensure that the food it produces is safe. ICAPP continues to work closely with federal and state authorities and is conducting this recall in cooperation with FDA.
For questions or more information, consumers may contact ICAPP by email at customerservice@icapp.com.eg or by phone, between 9:00 am and 5:00 pm Cairo local time, at +201-541-1624.
John