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Pigs Ears, Antiseptic Wipes, Food Thickener Recalled

Recall-SidebarDog treats, supplemental nutritionals and antiseptic wipes were the subject of recall this week by the U.S. Food and Drug Administration.

 

 

Pigs Ears Pet Treats

Bravo! is voluntarily recalling select boxes of Bravo! Pig Ears Chews because it has the potential to be contaminated with Salmonella. The products affected by this recall includes only Bravo! 50 ct bulk Oven roasted Pig Ears Product Code: 75-121 Lot # 12-06-10.

recallpigsearsSalmonella can affect animals and there is a risk to humans from handling contaminated pet products, especially if they have not thoroughly washed their hands after having contact with the chews or any other surfaces exposed to these products.

Healthy people with Salmonella should monitor themselves for some or all of the following symptoms including, nausea, vomiting, diarrhea or bloody diarrhea, abdominal cramping and fever. Rarely, Salmonella can result in more serious ailments, including arterial infections, endocarditis, arthritis, muscle pain, eye irritation and urinary tract symptoms. Consumers exhibiting these signs after having contact with this product should contact their healthcare provider.

Pets with Salmonella infections may be lethargic and have diarrhea or bloody diarrhea, fever and vomiting. Some pets will have only have decreased appetite, fever and abdominal pain. Infected but otherwise healthy pets can be carriers and infect other animals or humans. If your pet has consumed the recalled product and has these symptoms, please contact your veterinarian.

The company has received no reports of illness in either people or animals associated with the product. Bravo! is issuing this action out of an abundance of caution and sincerely regrets any inconvenience to pet owners as a result of this announcement.

Bravo! Pig Ears were distributed to retailers on the East and West Coasts. They were shipped to distributors and retailers between January 1 and February 28, 2011, where they were available for purchase.

The recall is the result of routine sampling program by the Washington State Department of Agriculture which revealed that the finished products contained the bacteria. The company has no product left in inventory from this batch of pig ears.

Consumers who have purchased any of these pig ears are urged to return the product to the place of purchase for a full refund. Consumers with questions about the recall, should visit www.bravorawdiet.com2 or call toll free 1.866.922.9222 9 am to 5 pm Monday to Friday.

recallsimplythick

Food Thickener

Simply Thick, LLC is announcing a voluntary recall of its SimplyThick® thickening gel products manufactured at a food processing plant located in Stone Mountain, Georgia since June 1, 2009. This plant is currently owned and operated by Thermo Pac, LLC. This voluntary recall is limited to only those products manufactured at the Stone Mountain, Georgia plant. Simply Thick products manufactured at two additional food processing plants are not subject to this voluntary recall.

For information on how to identify the products subject to this voluntary recall, please see the section below: How To Determine If The Product Was Manufactured At The Stone Mountain GA Plant.

WHY THE VOLUNTARY RECALL WAS ANNOUNCED
The SimplyThick® thickening gel products manufactured at the Thermo Pac, LLC Stone Mountain plant are being recalled because the U.S. Food and Drug Administration (FDA) advised the company that Thermo Pac, LLC failed to file with the FDA a scheduled process designed to ensure that vegetative cells (harmful bacteria) of possible public health significance are destroyed during the manufacturing process. This failure was discovered during an FDA inspection of the Thermo Pac, LLC Stone Mountain plant conducted from May 23 through June 3, 2011.

HOW TO IDENTIFY THE PRODUCT
Products manufactured at the Stone Mountain, GA plant subject to the voluntary recall were distributed across the United States and Canada through food service distributors, drug distributors, retail outlets (consisting primarily of pharmacies and durable medical equipment suppliers), medical facilities, and directly to consumers.

HOW TO DETERMINE IF THE PRODUCT WAS MANUFACTURED AT THE STONE MOUNTAIN GA PLANT

Products affected are 15 g, 30 g, 120 g and 240 g pouches.
All 15 g pouches are affected
All 30 g pouches are affected
Some 120 g pouches – identified as those with a “TP” in the lot code stamped into the edge of the packet.
Some 240 g pouches – identified as those with a “TP” in the lot code stamped into the edge of the packet.

SimplyThick item numbers affected
ALL 01001, 01005, 01007, 02001, 02005, and 02007
SOME 01004, 02004, 01006 and 02006 – identified as those with a “TP” in the lot code stamped into the edge of the packet.
SimplyThick item numbers are included as part of the UPC barcode on our packaging. The item number is the second group of 5 digits in the UPC barcode.

All products have a code embossed or stamped in the foil. The first 6 digits of that code represent a “best if used by” date in MMDDYY format. ANY date code that falls between 062610 (i.e. June 26, 2010) and 062612 (i.e. June 26, 2012) and contains the letter code “TP” in the code are affected by the recall.

An example of an affected date code is: 0312125TP1. The code breakdown would be the “Best If Used By Date”, 03/12/12 – i.e. March 12, 2012 AND it contains “TP” in the code . A picture of a packet with this date code can be found on our website.

A complete list of affected date codes will be posted on the SimplyThick website at www.simplythick.com/recalleddatecodes1 within the next day.

Products NOT affected by the recall:
64 oz bottles
Some 120 g pouches – identified as those with a “W” in the lot code stamped into the edge of the packet.
Some 240 g pouches – identified as those with a “W” in the lot code stamped into the edge of the packet.

SimplyThick item numbers NOT affected:
05000, 05005, 05010
SOME 01004, 02004, 01006 and 02006 – identified as those with a “W” in the lot code stamped into the edge of the packet.
SimplyThick item numbers are included as part of the UPC barcode on our packaging. The item number is the second group of 5 digits in the UPC barcode.

Example of a date code NOT affected by recall: 04051211WB. “Best If Used By Date” is 04/05/12 – i.e. April 5, 2012 AND it contains “W” in the code. A picture of a packet with this date code can be found on our website.

SHOULD THE FDA WARNING CONTINUE TO BE FOLLOWED REGARDING PREMATURE BABIES?

Yes. On May 20, 2011, the company notified our customers and medical professionals in Canada and in the United States to follow the FDA’s and the Canadian Food Inspection Agency’s (CFIA) warning not to give SimplyThick® brand thickener to infants born before 37 weeks gestation who are currently receiving hospital care or have been discharged from the hospital in the past 30 days, pending the results of our, the FDA’s and the CFIA’s investigations.

At this time, Simply Thick has not been advised by the FDA as to whether there is a relationship between the FDA’s previous warning and the FDA’s recent discovery that Thermo Pac, LLC failed to file a certain process with the agency.

Until the FDA, the CFIA and our company have completed our investigations, we continue to warn against the use of SimplyThick® brand thickener with infants born before 37 weeks gestation who are currently receiving hospital care or have been discharged from the hospital in the past 30 days regardless of whether or not the product is affected by the recall.

WHAT TO DO IF YOU HAVE PRODUCTS MANUFACTURED AT THE STONE MOUNTAIN GA PLANT THAT ARE SUBJECT TO THE VOLUNTARY RECALL

Anyone who has purchased or who has SimplyThick® thickening gel products manufactured at a food processing plant located in Stone Mountain, Georgia is urged to contact the company directly at 1-800-205-7115 for a full refund or an exchange for product(s) unaffected by the recall. Consumers with questions may contact the company at its toll free number 1-800-205-7115 24 hours a day, or by email at latestinfo@simplythick.com.

Alcohol Wipes

Churchill Medical Systems, A Vygon Company, is initiating a nationwide recall of certain lots of 5 hospital-use convenience kits. These products contain Skin-Prep Wipes that were affected by an April 2011 recall initiated by Smith & Nephew due to the potential for bacterial contamination. The Skin-Prep Wipes were manufactured in the same facility as The Triad Group’s affected products. Testing was conducted by Smith & Nephew on product lots distributed and in quarantine and no contamination has been found to date. No injuries have been reported to Vygon as a result; however, Vygon is initiating this recall out of an abundance of caution as use of contaminated Skin-Prep Wipes could lead to life-threatening infections, especially in at risk populations, including immune suppressed and surgical patients. FDA has been apprised of this action.

The convenience kits were shipped to distributors and hospitals between September 3, 2010 and March 11, 2011. Consumers who have the following product lots of the 5 convenience kits named below should cease use and coordinate the return and replacement of product with Vygon immediately.

Product Code

Product Name

Lot Number

AMS-7080CP

Dressing Change Kit

10J29

10J55

11A18

11A47

11B06

AMS-8316CP-1

Central Line Dressing Kit

10I60

10K42

10F87

AMS-8431CP

PICC Insertion Tray

10H30

AMS-9189CP-1

Dressing Change Kit

1006150

 

 

1006149

 

 

1008143

AMS-9189CP

Dressing Change Kit

1003527

Consumers with questions should contact Vygon’s Customer Service Department Monday through Friday from 8:30 am and 6:00 pm Eastern Time at 1-800-473-5414.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Online: www.fda.gov/medwatch/report.htm11

Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm22.
Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787

Fax: 1-800-FDA-0178