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WormGuy

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  1. http://www.emergencyemail.org/newsemergency/anmviewer.asp?a=6823&z=63 RECALL: Children's Ride-On Vehicles Peg Perego Recalls Children's Ride-On Vehicles Due to Fire and Burn Hazards (Recall Alert) Recall date: October 27, 2016 Recall Summary Name of product: Children's riding toy vehicles Hazard: A relay on the circuit board can fail causing the vehicle's motor to overheat and ignite, posing fire and burn hazards. Remedy: New Instructions, Replace Consumer Contact: Peg Perego toll-free at 877-737-3464 from 8 a.m. to 5 p.m. ET Monday through Friday, email at 850recall@pegperego.com or online at http://us.pegperego.com and click on Customer Service and then on Recalls for more information. Recall Details Units: About 3,000 Description: This recall involves Peg Perego's 850 Polaris Sportsman ride-on, 24-volt battery operated toy vehicles intended for children ages 5 to 7 years. The ATV-style vehicles for two people are silver, red and black and have four wheels, a flip-up backrest for the back passenger and a front and rear luggage rack. Vehicles with date codes 651016, 651017, 651020, 651021, 651022, 651023, 651024, 651027, 651028, 651029, 651030, 660304, 660305, 661123, 661124, 661125 and 661130 are included in this recall. The date code can be found underneath the vehicle seat. Sportsman Twin and 850 EFI appear on the side of the ride-on vehicle and Polaris appears on the side of the vehicle's seat. Incidents/Injuries: Peg Perego has received three reports of the children's ride-on toy vehicles overheating, including one report of a burn. Remedy: Consumers should immediately stop children from using the recalled toy vehicles and contact Peg Perego to receive a free replacement circuit board with instructions, including shipping. Consumers can also access the installation instructions on the firm's website. Peg Perego is contacting known customers directly. Sold At: Online retailers including Amazon.com, Cabelas.com, Target.com, ToysRUs.com and Wal-Mart.com from October 2014 through April 2016 for between $500 and $600. Manufacturer(s): Peg Perego USA, of Fort Wayne, Ind. Manufactured In: United States John
  2. 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
  3. http://www.fda.gov/Safety/Recalls/ucm527207.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. 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 news@mdlz.com +1-847-943-5678 Announcement View Product Photos http://www.fda.gov/Safety/Recalls/ucm527207.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery#recall-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
  4. 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: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm527148.htm John
  5. http://www.fda.gov/Safety/Recalls/ucm526992.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. 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 Eva.Pereira@rfbinder.com 781-559-0424 Announcement View Product Photos http://www.fda.gov/Safety/Recalls/ucm526992.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery#recall-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
  6. http://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2016/recall-101-2016-release 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 Press@fsis.usda.gov 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 http://www.fsis.usda.gov/wps/wcm/connect/cf16a4d0-6bb3-48a5-ad5c-b6267d6fef29/101-2016-labels.pdf?MOD=AJPERES 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
  7. http://www.fda.gov/Safety/Recalls/ucm526844.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. 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 http://www.fda.gov/Safety/Recalls/ucm526844.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery#recall-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
  8. http://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2016/recall-091-2016-release-exp 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 http://www.fsis.usda.gov/wps/wcm/connect/7bb109cb-fa84-4b50-85b1-f4715df8af35/RC-091-2016-Retail-List.pdf?MOD=AJPERES&CONVERT_TO=url&CACHEID=7bb109cb-fa84-4b50-85b1-f4715df8af35 Congressional and Public Affairs Allie Ryan Sarah R. Lichtman (202) 720-9113 Press@fsis.usda.gov 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 http://www.fsis.usda.gov/wps/wcm/connect/1f1541b9-d9da-4d47-9e1a-7d3ee76883bb/091-2016-exp-labels.pdf?MOD=AJPERES 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
  9. 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
  10. http://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2016/recall-100-2016-release 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 Press@fsis.usda.gov 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 http://www.fsis.usda.gov/wps/wcm/connect/6d92e296-fbba-4a80-a715-4132e514264f/100-2016-labels.pdf?MOD=AJPERES 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
  11. http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/MedicationHealthFraud/ucm526500.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery 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 http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/MedicationHealthFraud/ucm234592.htm 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 druginfo@fda.hhs.gov 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
  12. http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm526317.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery 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
  13. http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm526212.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery 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
  14. http://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2016/recall-099-2016-release 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 Press@fsis.usda.gov 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 http://www.fsis.usda.gov/wps/wcm/connect/407d3c16-93ab-4c58-bfcd-fe5abd560cf2/099-2016-labels.pdf?MOD=AJPERES 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
  15. http://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2016/recall-098-2016-release 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 Press@fsis.usda.gov 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 http://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2016/recall-098-2016-release/!ut/p/a1/jZFRa4MwFIV_yx58jLmpRXRvIrjVrUop69K8jOiihqVGonN0v35xg0KLZc19SS7f4dyTixmmmLV8lDUfpG65mt7Mf4MN-CSMIc2TKIFV5iW7IHsgkPsW2J8BIZmA3SZ_imMIMu9G_ZUTwX_69AaDhVnH6xqzjg8Nkm2lMTWi5EqhkvcCcVM2chSYni4LIP6JgTBAUwMZoYTl8Stm56ZAbFnT7fIxzTzIl5fAzK_8Addj21y10sXvCvZRW3iBDWBEJYww7qex7WYYunsHHFCy_ejdWo_vQtnxzdEt9cGBOWGj-wHTWQHuDi_0-zmqtivEiuPX3Q_m5fBA/#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
  16. http://www.fda.gov/Safety/Recalls/ucm526155.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. 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 recall@brownwoodfarms.com 1-888-772-9444 Announcement View Product Photos http://www.fda.gov/Safety/Recalls/ucm526155.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery#recall-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
  17. 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
  18. 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
  19. 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
  20. http://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/recall-case-archive/archive/2016/recall-097-2016-release 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 http://www.fsis.usda.gov/wps/wcm/connect/4d86b3ab-1952-44ce-a591-76fc84d52c11/RC-097-2016-Retail-List.pdf?MOD=AJPERES&CONVERT_TO=url&CACHEID=4d86b3ab-1952-44ce-a591-76fc84d52c11 Congressional and Public Affairs Autumn Canaday (202) 720-9113 Press@fsis.usda.gov 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 http://www.fsis.usda.gov/wps/wcm/connect/bfc3aef4-1462-46c8-8c54-04a2bdde9009/097-2016-label.pdf?MOD=AJPERES 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
  21. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm526074.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery 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
  22. 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
  23. 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
  24. 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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