WormGuy
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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.
Yoma Myanmar Tea Co. Issues Allergy Alert on Undeclared Peanuts in Yoma Myanmar Tea Salad Snack
For Immediate Release
October 17, 2016
Contact
Consumers
Yoma Myanmar Tea Co.
617-412-6799
Announcement
View Product Photos
Yoma Myanmar Tea Co. of Allston, MA is voluntarily recalling the Yoma Myanmar brand “Tea Salad Snack” in Regular and Spicy, 7 oz., because the products may contain undeclared peanuts. People who have allergies to peanuts run the risk of serious or life-threatening allergic reaction if they consume these products.
The product comes in a 7 ounce, clear plastic package marked with an expiration date of 6/15/2018 stamped on the bottom.
The recalled “Tea Salad Snacks" were distributed nationwide in retail stores and through mail orders.
No illnesses have been reported to date in connection with this problem. The error was discovered during a routine sampling by the New York Department of Agriculture and Markets Division of Food Safety and Inspection.
The recall was initiated after it was discovered that the peanut-containing product was distributed in packaging that did not reveal the presence of peanuts. Subsequent investigation indicates the problem was caused by a temporary breakdown in the company's production and packaging processes.
Production of the product has been suspended until FDA and the company are certain that the problem has been corrected.
Consumers who have purchased 7 ounce packages of “Tea Salad Snack” in regular and spicy are urged to return them to the place of purchase for a full refund. Consumers with questions may contact the company at 617-412-6799.
John
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News Release
Chicharrones J&J Recalls Rendered Animal Fat (Pork Lard) Products Due To Misbranding and an Undeclared Allergen
Class I Recall
094-2016
Health Risk: High
Oct 12, 2016
Distribution List PDF
Congressional and Public Affairs
Veronika Medina
(202) 720-9113
WASHINGTON, Oct. 12, 2016 – Chicharrones J&J, a Santa Ana, Calif., establishment, is recalling approximately 2,064 pounds of pork lard products 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, and sodium nitrite, which are not declared on the product label.
The pork lard products were produced on various dates from June 16, 2016 through Oct.12, 2016. The following products are subject to recall:
View Label
1-lb, 2-lb and 3-lb plastic tubs of “Chicharrones J&J Rendered Animal Fat”
The products subject to recall bear establishment number “EST. 31638” inside the USDA mark of inspection. These items were shipped to various retail locations in California.
The problem was discovered on Oct.12, 2016 by a FSIS consumer safety during label verification activities.
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.
Media and consumers with questions about the recall can contact George Velazquez, HACCP Manager, at (714) 543-1310.
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.
Voluntary Recall Notice of McCormick 24 oz. Club Size Original Taco Seasoning Mix Due to Unlabeled Milk Allergen
For Immediate Release
October 5, 2016
Contact
Consumers
McCormick Consumer Affairs
1-800-632-5847
Announcement
View Product Photos
SPARKS, Md., McCormick & Company, Incorporated is initiating a voluntary class I recall of 24 oz. Club Size McCormick® Original Taco Seasoning Mix, UPC 52100302461 with best by date codes between June 27, 2018 and September 16, 2018 due to an unlabeled milk allergen.
This recall does not impact any other sizes of McCormick Taco Seasoning Mix or McCormick products.
A number of dairy free Original Taco Seasoning Mix 24 oz. bottles were incorrectly filled with Original Taco Seasoning containing whey. In sensitive individuals, an allergic reaction to milk can cause hives, stomach upset, vomiting and in very rare cases anaphylaxis.
To date, McCormick has received one notice of an allergic reaction related to the product covered by this recall.
The product subject to this recall is:
NAME OF PRODUCT AND PACK SIZE: Original Taco Seasoning Mix 24 oz bottle
CASE PACK: 12/case
UPC NUMBER: 52100302461
MCCORMICK ITEM NUMBER: 930246 or 900272507
SCC NUMBER ON SHIPPER: 52100302461 or 52100012476
AFFECTED DATE CODE FOR FOLLOWING ITEM NUMBERS:
932046 - BEST BY JUL 08 18 H through BEST BY SEPT 16 18 H
900272507 - BEST BY JUN 27 18 H through BEST BY SEPT 16 18 H
STATES SHIPPED TO: Nationwide
McCormick has alerted customers and grocery outlets to remove the product with the affected date codes from store shelves and distribution centers immediately, and to destroy this product in a manner that would prevent further consumption.
Consumers do not need to return the product to the store where it was purchased. Instead, consumers are urged to dispose of the recalled product and its container. Please contact McCormick Consumer Affairs at 1-800-632-5847, weekdays from 9:30 AM to 7:00 PM (Eastern Time), for a replacement or full refund, and with general inquires.
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.
Medtronic Announces Voluntary Recall of its Pipeline Embolization Device, Alligator Retrieval Device, X-Celerator Hydrophilic Guidewire, Ultraflow and Marathon Flow Directed Micro Catheters
For Immediate Release
October 14, 2016
Contact
Consumers
Medtronic Lifeline Service
1-877-526-7890
Announcement
Medtronic plc (NYSE: MDT) today announced that it has notified customers of a voluntary recall of certain lots of its Pipeline™ embolization device, Alligator™ retrieval device and X-Celerator™ hydrophilic guidewire. The recall also includes the stylet containing UltraFlow™ flow directed micro catheters and Marathon™ flow directed micro catheters. These products are produced, marketed and sold by Medtronic's Neurovascular business, which is part of the Brain Therapies division in the company's Restorative Therapies Group.
This voluntary recall is being conducted due to the potential separation and detachment of the polytetrafluoroethylene (PTFE) coating on parts of these devices. Should the PTFE separate from the delivery wire or stylets, PTFE particulate could enter the blood stream of the patient. PTFE in the blood stream, based on the size and quantity, could lead to a thromboembolic event.
Medtronic initiated customer communication of the recall by letter on October 5, 2016, and is requesting customers to quarantine all affected product that remain in the inventory and return to Medtronic. The U.S. Food and Drug Administration (FDA) and other regulatory bodies also have been notified.
At the initiation of this recall, 84,278 units potentially affected by this recall had been distributed worldwide. The products were manufactured from July 2014 to September 2016. Additional information about the recall, including the specific lot numbers of affected product, can be found at http://bit.ly/2dTvety.
Medtronic is taking this voluntary action as a precaution and has received no reports of patient injuries to date related to this issue. The full recalled product list of affected lot totals is itemized below:
Product Name
Number of Affected Lots
Pipeline™ embolization device
1742
Alligator™ retrieval device
171
X-Celerator™ hydrophilic guidewires
210
UltraFlow™ HPC flow directed micro catheters/ Marathon™ flow directed micro catheters
1790
The Pipeline™ embolization device is indicated for the endovascular treatment of adults (22 years of age and older) with large or giant wide-necked intracranial aneurysms in the internal carotid artery from the petrous to the superior hypophyseal segments. The first generation Pipeline™ embolization device is affected by this action due to the PTFE coated delivery wire, which is part of the disposable delivery system (the braid implant is not affected). The second-generation device, Pipeline™ Flex embolization device, is not affected by this recall.
The Alligator™ retrieval device is intended for use in the peripheral and neuro-vasculature for foreign body retrieval. The X-Celerator™ hydrophilic guidewire is indicated for general intravascular use to aid in the selective placement of catheters in the peripheral, visceral and cerebral vasculature during diagnostic and/or therapeutic procedures. The UltraFlow™ flow directed micro catheter is designed for the subselective infusion of physician-specified therapeutic agents such as embolization materials and diagnostic materials such as contrast media in tortuous, distal vessels. The Marathon™ Flow Directed Micro Catheter is intended to access peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization materials and of diagnostic materials such as contrast.
Adverse reactions or quality problems experienced with the use of these products may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax:
Complete and submit the report Online: www.fda.gov/medwatch/report.htm
Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.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.
For information or to report a problem, please contact the Medtronic Lifeline Service at any time at +1-877-526-7890.
About Medtronic
Medtronic plc (www.medtronic.com), headquartered in Dublin, Ireland, is among the world's largest medical technology, services and solutions companies – alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 88,000 people worldwide, serving physicians, hospitals and patients in approximately 160 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
John
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It's in the upper North West corner near Memphis Tn.
John
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Good, used as an adjective, noun, or adverb.
Definition=I have almost too many jars now. Key word is "almost". I could get them but I'm concerned if I do I may have to sleep with them & I don't think they would be comfortable to snuggle up to.
John
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Michigan Turkey Producers Recalls Turkey Products Due To Possible Foreign Matter Contamination
Class I Recall
097-2016
Health Risk: High
Oct 15, 2016
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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I'm good this time.
John
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*Snip
350,000 vehicles recalled for dangerous brake issue
Honda is recalling more than 350,000 2016 Civics over a brake issue. There is a problem with software in the Vehicle Stability Assist Electronic Control Unit (VSA ECU).
It's possible that when the engine is off, the electric parking brake might not engage. That means the car could roll away and crash into something. The recall covers both the Civic Coupe and Sedan as well as both the 1.5-liter turbo and 2-liter engines.
The problem seems to only occur when the parking brake is applied after the engine is turned off. If it's applied while the car is still running, the defect won't show up.
Honda told the National Highway Traffic Safety Administration that the problem can be fixed by updating the software.
You can call Honda's customer service with any questions. Honda's number for this recall is KC6.
John
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News Release
Tyson Foods Recalls Frozen Popcorn Chicken Products Due To Possible Foreign Matter Contamination
Class I Recall
096-2016
Health Risk: High
Oct 15, 2016
Congressional and Public Affairs
Autumn Canaday
(202) 720-9113
WASHINGTON, Oct. 15, 2016 – Tyson Foods, a New Holland, Pa. establishment, is recalling approximately 1,148 pounds of frozen popcorn chicken products that may be contaminated with extraneous materials, specifically hard plastic, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
The frozen, ready-to-eat, whole grain popcorn chicken items were produced on August 10, 2016. The following products are subject to recall:
View Label
35 cases of 32.79-lb. “TYSON FULLY COOKED, WHOLE GRAIN GOLDEN CRISPY POPCORN CHICKEN, CHICKEN PATTIE FRITTERS” with a case code of “70368/928” on the upper right hand side of the label.
The products subject to recall bear establishment number “P-1325” inside the USDA mark of inspection. These items were shipped to a wholesale distributor in Illinois and further distributed to schools and food services in Missouri and Illinois.
The problem was discovered when the establishment received a consumer complaint from a school regarding foreign material, specifically hard plastic, found inside a bag of Tyson brand whole grain popcorn chicken product.
There have been no confirmed reports of injury or illness 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 Christina Self, food service consumer representative, at (866) 886-8456. Media with questions about the recall can contact Worth Sparkman, manager of public relations, at (479) 290-6358.
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.
Turkey Hill Dairy Issues Class I Voluntary Recall of Select Dutch Chocolate Premium Ice Cream - 48 oz. size
For Immediate Release
October 7, 2016
Contact
Consumers
Turkey Hill Dairy
1-800-693-2479
Media
Andrea Nikolaus
andrea.nikolaus@turkeyhill.com
Office:(717) 842-2331
Cell:(717) 371-6368
Melissa Mattilio
melissa.mattilio@turkeyhill.com
Office:(717) 842-2340
Cell:(717) 368-0059
Dave Shoffner
Office:(717) 234-8886
Cell:(717) 649-7905
Announcement
View Product Photos
Lancaster County, PA - Turkey Hill Dairy of Conestoga, Pa., is recalling select 48 oz. containers of its Dutch Chocolate Premium Ice Cream because the package may contain Rocky Road Premium Ice Cream instead of Dutch Chocolate Premium Ice Cream.
These packages may include undeclared ingredients of ALMONDS and EGGS, and could be harmful to consumers with food sensitivity or allergy to these ingredients.
The cup of the affected package would read Dutch Chocolate Premium Ice cream and the package lid would read Rocky Road Premium Ice Cream.
The recalled product information includes:
Name of product: Dutch Chocolate Premium Ice Cream
Container size: 48 oz. (1.5 QTS - 1.42L) UPC code: 20735-42095
Sell-by date: May 23, 2017 (Found printed on the bottom of the package)
The recalled Dutch Chocolate Premium Ice Cream is limited to packages with a sell by date of May 23, 2017 and sold at stores in PA., NY., NJ., MA., CT., DE., MD., VA., WV., AL., MO., OH., RI., ME., VT., NH., NC., SC., GA., MI., IN., KY,. MS., IL. and TN. All affected stores have been instructed to
remove the product from their shelves.
All affected packages would have been purchased by consumers after 09/08/2016.
Turkey Hill Dairy has not received any consumer illness complaints concerning this product recall. For consumers who are not allergic to almonds and eggs, there is no safety issue with the product.
Consumers who have purchased affected packages of Dutch Chocolate Premium Ice Cream - 48 oz. with the code date on May 23, 2017 can return them to the place of purchase for a full refund or contact Turkey Hill Dairy at 1-800-MY-DAIRY(1-800-693-2479).
Located in the rich farming country of Lancaster County, Pa., Turkey Hill Dairy produces the fifth largest-selling premium ice cream brand and one of the leading refrigerated iced tea brands in the nation. Over the past 20 years, Turkey Hill has tripled in size and now sells products in 49 states and a dozen countries on three continents. Guided by traditional values and inspired by its family- owned heritage, Turkey Hill Dairy considers all of its associates, partners and customers a part of the Turkey Hill family. The company believes part of its corporate responsibility is to be a good steward of its resources, community, and the world, and is actively defining and implementing green initiatives to cut down on waste, reduce packaging, and minimize outputs into the environment. To put its core values of sustainability into practice, Turkey Hill even generates 25 percent of the Dairy’s annual electricity needs by harnessing wind power through its own wind turbines located onsite at the Dairy. For more information on Turkey Hill Dairy, visit turkeyhill.com, read its blog, the Ice Cream Journal, or follow Turkey Hill Dairy on Twitter or on Facebook.
John
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News Release
National Meat and Provisions Recalls Beef and Veal Products Due To Possible E. Coli O26 Contamination
Class I Recall
095-2016
Health Risk: High
Oct 14, 2016
Congressional and Public Affairs
Autumn Canaday
(202) 720-9113
WASHINGTON, Oct. 14, 2016 – National Meat and Provisions, a Reserve, La. establishment, is recalling approximately 2,349 pounds of beef and veal products that may be contaminated with E. coli O26, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
The raw non-intact beef and veal items were produced and packaged on Sept. 14-15, 2016. The following products are subject to recall:
View Labels
PDF Only
51.40-lb. of VACUUM-PACKED “BEEF GROUND COMPANY BURGER BLEND,” packed on 9/14/2016 with a lot number of “00028584” and case codes of 53085/CB136 in the upper left-hand corner of the label
50.00-lb. of VACUUM-PACKED “BEEF GROUND COURSE STEAK TRIM,” packed on 9/14/2016 with a lot number of “00028582” and case codes of 53080/02300H in the upper left-hand corner of the label
10.00-lb. of VACUUM-PACKED “BEEF GROUND FRESH,” packed on 9/14/2016 with a lot number of “00028583” and case codes of 53110/02300P in the upper left-hand corner of the label
50.00-lb. VACUUM-PACKED “BEEF GROUND CHIMES FINE,” packed on 9/14/2016 with a lot number of “00028581” and case codes of 56660/02300C in the upper left-hand corner of the label
51.46-lb. VACUUM-PACKED “BEEF GROUND COMPANY BURGER BLEND,” packed on 9/15/2016 with a lot number of “00028597” and case codes of 53085/CB136 in the upper left-hand corner of the label
10.00-lb. VACUUM-PACKED “BEEF FAT OF RIB CAP,” packed on 9/15/2016, with a lot number of “00028595,” and case codes of 50010/1138 in the upper left-hand corner of the label
10.83-lb. VACUUM-PACKED “BEEF GROUND CHUCK DAT DOG,” packed on 9/15/2016, with a lot number of “00028593,” and case codes of 56135/02150 in the upper left-hand corner of the label
10.23-lb. VACUUM-PACKED “BEEF GROUND CHUCK BRISKET BURGER,” packed on 9/15/2016 with a lot number of “00028596,” and case codes of 53060/208116120 in the upper left-hand corner of the label
5.00-lb. VACUUM-PACKED “BEEF STEAK CUBED 5#,” packed on 9/15/2016, with a lot number of “00028594,” and case codes of 50565/04902 in the upper left-hand corner of the label
10.00-lb. VACUUM-PACKED “BEEF GROUND CHUCK 10#,” packed on 9/15/2016, with a lot number of “00028592,” and case codes of 53015/02100 in the upper left-hand corner of the label
10.11-lb. VACUUM-PACKED “BEEF STEAK CUBED,” packed on 9/15/2016, with a lot number of “00028591,” and case codes of 50555/1100GJ in the upper left-hand corner of the label
10.32-lb. VACUUM-PACKED “BEEF GROUND CHUCK BRISKET 8 oz.,” packed on 9/15/2016, with a lot number of “00028585,” and case codes of 53050/05M8 in the upper left-hand corner of the label
9.98-lb. VACUUM-PACKED “VEAL SIRLOIN CUBED POLY BAGED,” packed on 9/15/2016, with a lot number of “00028590,” and case codes of 56070/0776 in the upper left-hand corner of the label
The products subject to recall bear establishment number “EST. M-22022” inside the USDA mark of inspection. These items were shipped to a distributor, as well as hotels, restaurants and institutions in Louisiana.
The problem was discovered when the establishment received a positive STEC sample during their quarterly E. coli testing program on Sept. 29, 2016. There have been no confirmed reports of adverse reactions due to consumption of these products.
Many clinical laboratories do not test for non-O157 Shiga toxin-producing E. coli (STEC), such as STEC O26 because it is harder to identify than STEC O157. People can become ill from STECs 2–8 days (average of 3–4 days) after consuming the organism. Most people infected with STEC O26 develop diarrhea (often bloody), and vomiting. Some illnesses last longer and can be more severe. Infection is usually diagnosed by testing of a stool sample. Vigorous rehydration and other supportive care is the usual treatment; antibiotic treatment is generally not recommended.
Most people recover within a week, but, rarely, some develop a more severe infection. Hemolytic uremic syndrome (HUS) is uncommon with STEC O26 infection. HUS can occur in people of any age but is most common in children under 5 years old, older adults and persons with weakened immune systems. 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 beef or veal that has been cooked to a temperature of 145° F with a three minute rest time. The only way to confirm that beef and veal are 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 Amy Philpott, spokesperson, at (703) 472-6615.
John
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Skintact DF29N Multi-function Defibrillation Electrodes by Leonhard Lang: Class I Recall - Connector Compatibility Issue
[Posted 10/14/2016]
AUDIENCE: Risk Manager, Emergency Medicine, Patient
ISSUE: The Leonhard Lang defibrillation electrode is being recalled due to a connector compatibility issue with the Welch Allyn AED model 10. The user may not be able to connect the electrodes to the defibrillator when a shock is needed. This may result in a delay in delivering the electrical therapy needed to revive a patient in cardiac arrest.
A delay in therapy could result in serious patient injury and/or death.
Recalled product details:
50028 Defibrillation Electrode SKINTACT DF29N
Lot Numbers: 60602-0774, 60502-0779, 60308-0771,60114-0773, 51023-0775, 50904-0777, 50403-0778, 50130-0777, 41023-0771, 41008-0778 40730-0778, 40618-0778, 40130-0776
Distribution Dates: February 14, 2014, to August 3, 2016
BACKGROUND: Automatic external defibrillators (AEDs) are used to deliver lifesaving electrical shocks to people with sudden cardiac arrest, a medical condition in which the heart suddenly and unexpectedly stops beating. Defibrillation electrodes are connected to the AED to help the device analyze a patient’s heart rhythm and deliver an electrical shock to restore normal heart rhythm when needed.
RECOMMENDATION: On September 1, 2016, Leonhard Lang sent an "Important Safety Notice" letter to all affected customers. The letter asked customers to:
Review the safety notice and ensure appropriate staff is aware of the notice.
Make sure all unused defibrillation electrodes DF29N are secured and destroyed.
Confirm the products were destroyed by completing the "Confirmation of Destruction / Consumption" form in the notice.
Send the "Confirmation of Destruction / Consumption" form to their supplier no later than October 14, 2016.
Keep the signed "Confirmation of Destruction / Consumption" form until their supplier informed them of the termination of this recall.
Health care professionals and consumers with questions are instructed to contact the Leonhard Lang sales staff at (800) 903-6199 with any questions related to this recall.
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
[10/14/2016 - Recall Notice - FDA]
http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm525244.htm
John
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FDA Updates on Multistate Outbreak of Burkholderia cepacia Infections
UPDATE [10/12/2016]: FDA and CDC find direct link of contaminated water at PharmaTech to the multistate B. cepacia outbreak
An FDA investigation associated with a multistate outbreak has identified the bacteria, Burkholderia cepacia in more than 10 lots of oral liquid docusate sodium manufactured by PharmaTech, Davie, Florida. The investigation also detected B. cepacia in the water system used to manufacture the product. These products were manufactured by PharmaTech and distributed and labeled by six firms – Rugby, Major, Bayshore, Metron, Centurion, and Virtus.
FDA also inspected other oral liquid docusate sodium manufacturers and collected samples of their products. The bacteria associated with this multistate outbreak has not been found in other oral liquid docusate sodium products FDA tested.
Laboratory evidence from FDA and CDC supports PharmaTech as the source of this outbreak.
In addition, FDA’s current laboratory results do not indicate the active pharmaceutical ingredient used to manufacture oral liquid docusate is a source of the B. cepacia outbreak.
Health care professionals may resume normal use of oral liquid docusate sodium not manufactured by PharmaTech.
FDA reminds manufacturers of the importance of robust manufacturing and testing of liquid products such as docusate sodium to ensure low levels of microorganisms and the absence of those that may cause infection.
FDA will continue to monitor adverse event reports for B. cepacia related to oral liquid docusate sodium. FDA also encourages health care professionals and patients to report adverse events or quality problems experienced with the use of oral liquid docusate sodium products to FDA’s MedWatch Adverse Event Reporting program:
Complete and submit the report online at www.fda.gov/medwatch/report.htm; or
Download and complete the form, then submit it via fax at 1-800-FDA-0178.
UPDATE [8/15/2016] FDA issues import alert for all drugs produced by Laxachem Organics in India
The U.S. Food and Drug Administration placed Laxachem Organics Pvt. Ltd., Ahmednagar, Maharashtra, India, on import alert on August 11, 2016, for refusing to allow FDA investigators to inspect its facility. The import alert stops all Laxachem pharmaceutical products from entering the United States legally.
Laxachem will remain on import alert until it has been fully inspected by FDA and found to meet U.S. standards.
Laxachem manufactures active pharmaceutical ingredient (API) for repackagers, labelers, and wholesale drug distributors, some of which sell API to manufacturing facilities in the United States. According to Laxachem’sdisclaimer icon website, one of the drugs Laxachem manufactures is Docusate Sodium USP.
Companies that received API from Laxachem should not distribute the API or products containing the API to customers.
Under the Federal Food, Drug and Cosmetic Act (FD&C Act), drugs, including APIs, made at a facility that denies, limits, or delays an FDA inspection are considered adulterated. The FD&C Act prohibits distribution of adulterated products.
For more information, see FDA guidance for industry, Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM360484.pdf
UPDATE [8/9/2016] FDA announces voluntary nationwide recall of all liquid products manufactured by PharmaTech and distributed by six companies
FDA is alerting health care professionals and consumers of PharmaTech’s voluntary recall expansion to include all liquid products due to possible Burkholderia cepacia contamination. These products were manufactured in its Davie, Florida, facility, and distributed and labeled by six firms – Rugby, Major, Bayshore, Metron, Centurion, and Virtus.
Consumers, pharmacies, and health care facilities that have product which is being recalled should stop using and dispensing them immediately. Using these products in a patient whose immune system is compromised could result in infections, which may be life-threatening.
To date, FDA has received adverse event reports related to oral liquid docusate sodium and is not aware of any adverse event reports related to the additional recalled products.
FDA and CDC will provide additional information when it is available.
[7/16/16] FDA announces voluntary nationwide recall of oral liquid docusate sodium manufactured by PharmaTech and distributed by Rugby Laboratories
U.S. Food and Drug Administration is alerting health care professionals that PharmaTech LLC, Davie, Florida, is voluntarily recalling all non-expired lots of Diocto Liquid, a docusate sodium solution distributed by Rugby Laboratories, Livonia, Michigan. The agency confirmed the product has been contaminated with Burkholderia cepacia, a bacteria linked to an outbreak in five states.
PharmaTech manufactures the oral liquid docusate sodium, which is distributed nationwide by Rugby with a Rugby label in one pint (473 mL) bottles.
In addition, FDA has received several adverse event reports of B. cepacia infections in patients. Some of these reports identify liquid docusate sodium products manufactured by companies other than PharmaTech. FDA and the Centers for Disease Control and Prevention continue to investigate the extent of this issue in order to identify other potentially contaminated liquid docusate sodium products.
Patient safety is our top priority. FDA joins CDC in recommending that clinicians not use any liquid docusate sodium product as a stool softener or for any other medical purpose.
FDA and CDC will provide additional information when it is available.
FDA encourages health care professionals and patients to report adverse events or quality problems experienced with the use of oral liquid docusate sodium products to FDA’s MedWatch Adverse Event Reporting program:
Complete and submit the report online at www.fda.gov/medwatch/report.htm; or
Download and complete the form, then submit it via fax at 1-800-FDA-0178.
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 and Recall of Products Based on Possible Health Risk Associated With Undeclared Soy or Yellow #5 Food Coloring
For Immediate Release
October 7, 2016
Contact
Consumers
Brownwood Farms
1-888-772-9444
Announcement
View Product Photos
Brownwood Farms of Williamsburg, MI is recalling approximately 15,000 total units of the listed products, because they contain undeclared soy or Yellow #5 food coloring. People who have an allergy or severe sensitivity to soy or Yellow #5 food coloring 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 SOY IN THE FOLLOWING PRODUCTS:
YANKEE BOURBON BBQ SAUCE 19 oz. - UPC 18303-00519 - with best by dates before 09/21/2018
YANKEE BOURBON BBQ SAUCE - 1 Gallon - with best by dates before 09/21/2018
CHERRY BBQ SAUCE 21 oz. - UPC 18303-00506 - with best by dates before 09/21/2018
CHERRY BBQ SAUCE - 1 Gallon with best by dates before 09/21/2018
CHERRY BBQ SAUCE - 5 Gallon with best by dates before 9/21/2018
BBQ MUSTARD GLAZE 11 oz. - UPC 18303-00580 - with best by dates before 09/21/2018
BBQ MUSTARD GLAZE - 1 Gallon with best by dates before 09/21/2018
AND
BROWNWOOD FARMS ISSUES ALLERGY ALERT ON UNDECLARED YELLOW #5 FOOD COLORING IN THE FOLLOWING PRODUCTS:
APPLE RIESLING SALSA 21 oz. - UPC 18303-00518 - with best by dates before 09/30/2017
APPLE RIESLING SALSA - 1 Gallon - with best by dates before 09/30/2017
PEACH SALSA 17 oz. - UPC 18303-00520 - with best by dates before 09/30/2017
JALAPENO CHERRY SALSA 21 oz. - UPC 18303-00510 - with best by dates before 09/30/2017
JALAPENO CHERRY SALSA - 1 Gallon - with best by dates before 09/30/2017
JALAPENO CHERRY BUTTER 12 oz. - UPC 18303-00513 - with best by dates before 09/30/2018
JALAPENO CHERRY BUTTER - 1 Gallon - with best by dates before 09/30/2018
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 soy or Yellow #5 food coloring and the packaged product did not have labels indicating their presence.
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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Stӧckert 3T Heater-Cooler System by LivaNova PLC (formerly Sorin Group Deutschland GmbH): UPDATED Safety Communication - Reports of Mycobacterium Chimaera Infections
AUDIENCE: Risk Manager, Cardiology, Surgery, Infectious Disease, Nursing
ISSUE: FDA is updating its June 1, 2016 Safety Communication to provide new information about Mycobacterium chimaera (M. chimaera) infections associated with the use of the Stӧckert 3T Heater-Cooler System (3T) in U.S. patients who have undergone cardiothoracic surgeries. This communication also contains updated recommendations to help prevent the spread of infection related to the use of these devices. For the complete list of recommendations, see the updated FDA Safety Communication.
BACKGROUND: Heater-cooler devices are commonly used during cardiothoracic surgeries, as well as other medical and surgical procedures, to warm or cool a patient in order to optimize medical care and improve patient outcomes. Heater-cooler devices have water tanks that provide temperature-controlled water to external heat exchangers or warming/cooling blankets through closed circuits. Although the water in the circuits does not come into direct contact with the patient, there is the potential for contaminated water to enter other parts of the device and aerosolize, transmitting bacteria through the air and through the device's exhaust vent into the environment and to the patient. In October 2015, the FDA issued a Safety Communication to provide recommendations to help minimize patient risk of infections associated with heater-cooler devices. Since issuing that communication, the FDA has continued to evaluate the causes and risk factors for transmission of microbial agents associated with heater-cooler devices and has collaborated with professional societies, public health partners, and experts to develop strategies to minimize patient exposure.
RECOMMENDATIONS: UPDATED recommendations for health care facilities and staff:
If your facility uses 3T devices, you should:
Immediately remove from service any heater-cooler devices, accessories, tubing, and connectors that have tested positive for M. chimaera or have been associated with known M. chimaera patient infections at your facility.
Use new accessories, tubing, and connectors to prevent recontamination when using a different heater-cooler device.
Direct and channel the heater-cooler exhaust away from the patient, e.g., to the operating room exhaust vent.
Be aware that device contamination also may occur from other sources such as environmental contamination or device contact with contaminated accessories.
Review the recommendations in CDC's Health Advisory
Be aware that heater-cooler devices are important in patient care. In appropriately selected patients, the benefits of temperature control during open chest cardiothoracic procedures generally outweigh the risk of infection transmission associated with the use of these devices.
If your facility has 3T devices manufactured prior to September 2014, you should:
Strongly consider transitioning away from the use of these devices for open-chest cardiac surgery until the manufacturer has implemented strategies for these devices to mitigate the risks of patient infection. ◦Use of these devices should be limited to emergent and/or life-threatening situations if no other heater cooler devices are available.
Follow the FDA's earlier recommendations to help mitigate the risks of patient infection.
Be aware that testing of heater-cooler devices to identify units contaminated with M. chimaera presents technical challenges related to sample collection, the long culture time, and the high rate of false negative tests. Therefore, it is not recommended at this time.
If your facility has 3T devices manufactured after September 2014, you should:
Follow the FDA's earlier recommendations to help mitigate the risks of patient infection.
Be aware that testing of heater-cooler devices to identify units contaminated with M. chimaera presents technical challenges related to sample collection, the long culture time, and the high rate of false negative tests. Therefore, it is not recommended at this time.
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 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 links to the FDA Safety Communication and CDC alerts, at:
John
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News Release
Kraft Heinz Recalls Ready-To-Eat Lunchables Ham and American Cracker Stackers Product Due to Misbranding and Undeclared Allergens
Class I Recall
093-2016
Health Risk: High
Oct 9, 2016
Distribution List PDF
Congressional and Public Affairs
Sarah R. Lichtman
(202) 720-9113
WASHINGTON, Oct. 9, 2016 – Kraft Heinz Company, a Fullerton, Calif. establishment, is recalling approximately 959 pounds of ready-to-eat “Lunchables Ham and American Cracker Stackers” packaged lunch 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 wheat and soy, known allergens, which are not declared on the product label.
The ready-to-eat meat and cheese packaged lunch items were produced on September 21, 2016. The following products are subject to recall:
View Labels PDF only
3.4-oz. boxes containing four-compartment plastic trays of “Lunchables Ham and American Cracker Stackers,” with a “USE BY” date of 25 DEC 2016 and production times ranging from 9:13 to 10:00 stamped on the side of the plastic container.
The products subject to recall bear establishment number “EST. 537K” inside the USDA mark of inspection. These items were shipped to retail locations in Utah and California.
The problem was discovered on October 6, 2016, when the firm received a consumer complaint. There were no illnesses associated with the complaint.
The establishment determined that the “Lunchables Ham and American Cracker Stackers” products were incorrectly labeled with the back label for a “Nacho Lunchable” product. The back label contains the product ingredient statements and as such, the “Lunchables Ham and American Cracker Stackers” products that were mislabeled do not declare wheat and soy on the label.
There have been no confirmed reports of adverse reactions due to consumption of this product. Anyone concerned about an injury or illness should contact a healthcare provider.
Consumers who have purchased this product are urged not to consume it. This product 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 the Kraft Heinz Consumer Relations Center, at 1-800-572-3877. Members of the media with questions about the recall can contact Lynne Gaila, Corporate Affairs Director, Kraft Heinz Company, at (847) 646-4396 or lynne.galia@kraftheinzcompany.com.
John
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News Release
Chicharrones J&J Recalls Rendered Animal Fat (Pork Lard) Products Due To Misbranding and an Undeclared Allergen
Class I Recall
094-2016
Health Risk: High
Oct 12, 2016
Congressional and Public Affairs
Veronika Medina
(202) 720-9113
WASHINGTON, Oct. 12, 2016 – Chicharrones J&J, a Santa Ana, Calif., establishment, is recalling approximately 2,064 pounds of pork lard products 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, and sodium nitrite, which are not declared on the product label.
The pork lard products were produced on various dates from June 16, 2016 through Oct.12, 2016. The following products are subject to recall:
View Label
1-lb, 2-lb and 3-lb plastic tubs of “Chicharrones J&J Rendered Animal Fat”
The products subject to recall bear establishment number “EST. 31638” inside the USDA mark of inspection. These items were shipped to various retail locations in California.
The problem was discovered on Oct.12, 2016 by a FSIS consumer safety during label verification activities.
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.
Media and consumers with questions about the recall can contact George Velazquez, HACCP Manager, at (714) 543-1310.
John
-
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.
Kuster's, Inc. Voluntarily Recalls Product Because Of Possible Health Risk
For Immediate Release
October 12, 2016
Contact
Consumers
Customer Service
517-368-5174
Announcement
View Product Photos
Camden, MI - Kuster's, Inc. of is voluntarily recalling 14,238 pounds of its shredded, sliced and cubed cheese out of an abundance of caution. Kuster's, Inc., was notified by its supplier, Farm Country Cheese, Lakeview, MI, that the cheese has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea. Listeria infection can cause miscarriages and stillbirths among pregnant women. Kuster's, Inc. is complying with this recall and recalling any product that may have been processed on its manufacturing equipment after the cheese in question was processed.
The shredded cheese was distributed in Michigan, Indiana, Illinois, Ohio and Pennsylvania.
Products included in this voluntary recall are: sharp white cheddar, mozzarella/muenster/provolone, Monterey Jack, pepper jack,four blend, three blend; pepper jack cubes; and co/jack slices .Product dates can be found in the bottom center of the label.
The shredded cheese was sold in 5 pound plastic bags under the Kuster's Dairy Foods, Fata's Best and Nor-Tech Dairy labels. Shredded cheese was packaged under the following labels:
Kuster's Dairy Foods Three Blend (pack date 10/05/16)
Fata's Best Four Blend Feather Shred (lot date 27916)
Fata's Best Mozzarella Muenster Provolone Feather Shred (lot date 27916)
Fata's Best Monterey Jack Feather Shred (lot date 27916)
Fata's Best PepperJack Feather Shred (Lot date 27816)
Nor-Tech Dairy Mozz/Muenster/Prov Feather Shred (best used by: 12-05-2016)
Nor-Tech Dairy Sharp White Cheddar Feather Shred (packed on 10.04.2016)
The cubed cheese was packaged under the following label:
Nor-Tech Dairy PepperJack 3/4" Cubed (packed on 10/04/2016).
The sliced cheese was packaged under the following label:
Kuster's Dairy Foods Sliced Colby Jack
No illnesses have been reported to date.
The recall was the result of confirmation from the cheese manufacturer of a possible contamination of the product received. Kuster's, Inc. has ceased production and distribution of the product as the FDA and the company continue their investigations.
Consumers who have purchased any of these products are urged not to consume the product and to return it to Kuster's, Inc. for a full refund. Customers with questions may contact the company at 517-368-5174 from 8:00 a.m. to 4:00 p.m. EST.
John
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Recall Date: October 12, 2016
Recall Number: 17-010
Mamas & Papas Recalls Armadillo Strollers Due to Fall Hazard
Recall Summary
Name of Product: Mamas & Papas Armadillo Flip Strollers
Hazard: A loose latch on the stroller can cause the seat to tip back unexpectedly when infant is in the parent-facing position, posing a fall hazard to infants.
Consumers should immediately stop using the strollers and contact Mamas & Papas for a free repair.
Consumer Contact: Mamas & Papas at 800-309-6312 anytime or online at www.mamasandpapas.com/us and click on Recall Notice for more information.
Photos available at: https://cpsc-prod.ctacdev.com/Recalls/2017/Mamas-and-Papas-Recalls-Armadillo-Strollers
Recall Details
Units: About 3,000 (In addition one was sold in Canada)
Description: This recall involves Mamas & Papas’ Armadillo Flip and Armadillo Flip XT strollers. All models are folding, single-occupant infant strollers. The strollers come in various colors including black, teal and navy and weigh about 22 pounds. Recalled items can be identified by their lot number, which is the month and year of manufacture. Lot numbers ranges for recalled Armadillo Flip strollers are 00814 through 00416 (August 2014 through April 2016). Lot number ranges for the Flip XT are 01214 through 00416 (December 2014 through April 2016). The lot number is printed on the sewn-in label on the stroller.
Incidents/Injuries: There have been 10 reports of seats tipping back. No injuries have been reported.
Sold at: Albee Baby, Babies ‘R’ Us, Buy Buy Baby and other stores nationwide and online at www.mamasandpapas.com and www.Amazon.com from December 2014 through July 2016 for between $500 and $550.
Importer: Mamas & Papas Ltd, of UK
Manufactured in: China
We continue to work closely with regulatory agencies, and remain committed to ensuring we are providing safe products for our consumers to enjoy. Consumers seeking information may call toll-free 1-866-293-8118, Monday through Friday, 7:00 a.m. to 12:00 a.m., and 8:30 a.m. to 5:00 p.m. on Saturdays and Sundays, Eastern Daylight Time.
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.
Nutrisystem Retail Division Voluntarily Recalls One Product Containing Chocolate Cookie Dough Pieces Purchased From Third Party Supplier Due To A Possible Health Risk
For Immediate Release
October 11, 2016
Contact
Consumers
Customer Service
1-866-293-8118
Media
Robin McConnell Shallow
215-346-8068
Announcement
View Product Photos
Fort Washington, PA - Nutrisystem Everyday, LLC, the retail division of Nutrisystem, Inc., is voluntarily recalling the Nutricrush Chocolate Chip Cookie Dough bar, manufactured by Noble Foods, Inc. This bar contains a chocolate chip cookie dough ingredient supplied by a third party supplier, which advised that its ingredient might potentially contain Listeria monocytogenes.
The product had very limited distribution of 1 lot/455 cases to ShopRite and Hannaford stores in Connecticut, Delaware, Massachusetts, Maryland, Maine, New Hampshire, New Jersey, New York, Pennsylvania, Rhode Island, Virginia, Vermont, and online through Amazon.com and Walmart.com. No other code dates of this product or other Nutrisystem® products in retail are affected. No Nutrisystem ‘direct to consumer’ product is impacted in any way.
Listeria monocytogenes is an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
This voluntary recall covers the Nutrisystem Nutricrush Chocolate Chip Cookie Dough Bar. The bar was sold as a 5-count carton. The product can be identified by the UPC 6 32674 85579 4, Enjoy by Aug 22 2017 and Lot Code NF082216A. All code information is found on the back panel of the carton.
Nutrisystem is initiating this recall out of an abundance of caution. This recall is being conducted in cooperation with the U.S. Food and Drug Administration (FDA). Consumers should not eat the recalled product. Consumers may discard the product or return it to the ShopRite or Hannaford from where it was purchased for a full refund. Twenty-four customers of Amazon.com and Walmart.com have already been identified, instructed to discard the product, and will be issued a refund. No illnesses have been reported.
John
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News Release
Daily's Premium Meats, LLC Recalls Bacon Products Due to Possible Listeria Adulteration
Class I Recall
092-2016
Health Risk: High
Oct 3, 2016
Congressional and Public Affairs
Nina Anand
(202) 720-9113
WASHINGTON, Oct. 3, 2016 – Daily’s Premium Meats, LLC, a Salt Lake City, Utah establishment, is recalling approximately 170 pounds of ready-to-eat bacon products that may be adulterated with Listeria monocytogenes, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.
The “Regular Ends Precooked Bacon” items were produced on September 22, 2016. The following products are subject to recall:
View Labels PDF only
17 CASES of 2-5 lbs. PACKAGES IN CARDBOARD BOXES, CONTAINING “48108 REGULAR ENDS PRECOOKED BACON NET WT. 10 lbs. 2/5 lbs.” with a packaging date of “9/22/16” and use by date of “6/19/17.
The products subject to recall bear establishment number “EST. 6133” inside the USDA mark of inspection. These items were shipped to Associated Foods retail locations in Idaho and Utah.
The problem was discovered during the company’s routine internal third party testing when a product sample collected tested positive for Listeria monocytogenes (Lm). There have been no confirmed reports of illness or adverse reactions due to consumption of these products.
Consumption of food contaminated with Listeria monocytogenes can cause listeriosis, a serious infection that primarily affects older adults, persons with weakened immune systems, and pregnant women and their newborns. Less commonly, persons outside these risk groups are affected.
Listeriosis can cause fever, muscle aches, headache, stiff neck, confusion, loss of balance and convulsions sometimes preceded by diarrhea or other gastrointestinal symptoms. An invasive infection spreads beyond the gastrointestinal tract. In pregnant women, the infection can cause miscarriages, stillbirths, premature delivery or life-threatening infection of the newborn. In addition, serious and sometimes fatal infections in older adults and persons with weakened immune systems. Listeriosis is treated with antibiotics. Persons in the higher-risk categories who experience flu-like symptoms within two months after eating contaminated food should seek medical care and tell the health care provider about eating the contaminated food.
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 reheat ready-to-eat product until steaming hot.
Consumers with questions regarding the recall can contact Barry VanderVeur, Vice President of Operations at (801)-707-6145. Media with questions regarding the recall can contact David Eaheart, Director of Communications and Marketing at (913)-302-9885.
John
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https://www.cpsc.gov/Recalls/2017/Specialized-Recalls-Road-Bicycles
Specialized Recalls Road Bicycles Due to Injury Hazard
Recall date: October 11, 2016
Recall number: 17-008
Recalled Specialized S-Works Venge Vias bicycle
Recall Summary
Name of product: Road bicycles
Hazard: The bicycles rear wheel can come out of the dropout causing fractures in the rear triangle; presenting an injury hazard to riders.
Consumer Contact:
Specialized at 800-722-4423 from 9 a.m. to 5 p.m. PT Monday through Friday or online at www.specialized.com on Safety Notices for more information.
Recall Details
Units:
About 1,000
Description:
This recall involves 2016 Specialized S-Works Venge Vias and Venge Pro Vias road bicycles. They were sold in black, white, red and black, white and black and green and blue color combinations. An S-works or Specialized decal can be found on the downtube.
Incidents/Injuries:
The firm has received seven reports of fractures in the bicycle’s rear triangle, including one report of a rider suffering a minor injury.
Remedy:
Consumers should immediately stop using the recalled bicycles and contact an Authorized Specialized retailer for free installation of a new rear derailleur hanger and a safety inspection.
Sold At:
Authorized Specialized Retailers from July 2015 through September 2016 for between $6,200 and $12,900.
Importer(s):
Specialized Bicycle Components Inc. (Specialized), of Morgan Hill, Calif.
Manufactured In:
China
John
-
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.
Publix Recalls Publix Premium Chocolate Chip Cookie Dough Ice Cream Due To Possible Listeria monocytogenes Contamination From Aspen Hills, Inc. Cookie Dough Pieces
For Immediate Release
October 10, 2016
Contact
Consumers
Customer Care department
1-800-242-1227
U.S. Food and Drug Administration
1-888-723-3366
Announcement
LAKELAND, Fla – Aspen Hills, the supplier of the cookie dough pieces used as an ingredient in the Publix Chocolate Cookie Dough Ice Cream, notified Publix that some of their product could be contaminated with Listeria monocytogenes. Publix Super Markets is issuing a voluntary recall for Publix Premium Chocolate Chip Cookie Dough Ice Cream due to the possibility of the product containing Listeria monocytogenes.
The ice cream was sold at Publix stores in Florida, Georgia, Alabama, South Carolina, Tennessee and North Carolina with a UPC of 000-41415-03843, and a sell by date of May 27 2017, which is printed on the bottom of the half gallon container.
Listeria monocytogenes is a bacteria that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
"As part of our commitment to food safety, potentially impacted product has been removed from all store shelves,” said Maria Brous, Publix media and community relations director. "To date, there have been no reported cases of illness. Consumers who have purchased the product in question may return the product to their local store for a full refund. Publix customers with additional questions may call our Customer Care department at 1-800-242-1227 or by visiting our website at www.publix.com. Customers can also contact the US Food and Drug Administration at 1-888-SAFEFOOD (1-888-723-3366).”
Publix is privately owned and operated by its 186,000 employees, with 2015 sales of $32.4 billion. Currently Publix has 1,127 stores in Florida, Georgia, Alabama, Tennessee, South Carolina and North Carolina. The company has been named one of Fortune’s “100 Best Companies to Work For in America” for 19 consecutive years. In addition, Publix’s dedication to superior quality and customer service is recognized among the top in the grocery business. For more information, visit the company’s website, corporate.publix.com.
John
Recall: Defibrillation Electrode
in Pinching Pennies
Posted
http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm525244.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery
Leonhard Lang Multi-function Defibrillation Electrodes DF29N Will Not Work with Welch Allyn Automatic External Defibrillator model AED 10
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:
50028 Defibrillation Electrode SKINTACT DF29N
Lot Numbers: 60602-0774, 60502-0779, 60308-0771, 60114-0773, 51023-0775, 50904-0777, 50403-0778, 50130-0777, 41023-0771, 41008-0778 40730-0778, 40618-0778, 40130-0776
Distribution Dates: February 14, 2014, to August 3, 2016
Devices Recalled in the U.S.: 8040 nationwide
Device Use
Automatic external defibrillators (AEDs) are used to deliver lifesaving electrical shocks to people with sudden cardiac arrest, a medical condition in which the heart suddenly and unexpectedly stops beating. Defibrillation electrodes are connected to the AED to help the device analyze a patient’s heart rhythm and deliver an electrical shock to restore normal heart rhythm when needed. The primary users of AEDs are first responders and hospital health care providers.
Figure: 50028 Defibrillation Electrode SKINTACT DF29N
Figure: 50028 Defibrillation Electrode SKINTACT DF29N
Reason for Recall
The Leonhard Lang defibrillation electrode is being recalled due to a connector compatibility issue with the Welch Allyn AED model 10. The user may not be able to connect the electrodes to the defibrillator when a shock is needed. This may result in a delay in delivering the electrical therapy needed to revive a patient in cardiac arrest.
A delay in therapy could result in serious patient injury and/or death.
Who May be Affected
Health care providers and first responders using this defibrillation electrode
Patients who may need this defibrillation electrode to restore normal heart rhythm
What to Do
On September 1, 2016, Leonhard Lang sent an "Important Safety Notice" letter to all affected customers. The letter asked customers to:
Review the safety notice and ensure appropriate staff is aware of the notice.
Make sure all unused defibrillation electrodes DF29N are secured and destroyed.
Confirm the products were destroyed by completing the "Confirmation of Destruction / Consumption" form in the notice.
Send the "Confirmation of Destruction / Consumption" form to their supplier no later than October 14, 2016.
Keep the signed "Confirmation of Destruction / Consumption" form until their supplier informed them of the termination of this recall.
Contact Information
Health care professionals and consumers with questions are instructed to contact the Leonhard Lang sales staff at (800) 903-6199 with any questions related to this recall.
Date Recall Initiated
September 1, 2016
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