—#100736

Product

RUSCH Urinary Drainage Bag, 2000 ml Product Usage: For one time use per the Directions for Use with urinary catheter for drainage of urine.

FDA product code: FAQ — Bag, Urine Collection, Leg, For External Use, Sterile
Device class: Class 1
Medical specialty: Gastroenterology, Urology
Affected lot / code info: Catalogue number: 390060, Lot number: 20100515 & 20100501; Catalogue number: 452919, Lot number: 20100405.

Why it was recalled

Sterile integrity cannot be guaranteed.

Root cause (FDA determination)

Other

Action the firm took

Teleflex Medical sent an " URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter dated June 2, 2011. The letter identified the product, the problem and the actions needed to be taken. The customers were instructed to immediately discontinue distribution, quarantine any affected products, communicate this recall to any of their customers using the provided customer letter, and complete and fax the enclosed Recall Acknowledgement Form to Customer Service at 1-866-804-9881. Once the fax is received instructions for product return will be provided to customers. In the event that an alternative approach is needed, customers are instructed to contact Teleflex Medical Customer Service at 1- 866-246-6990. For further questions contact your sales representative or Customer Service at 1-866-246-6990. The recall was expanded and an additional letter was sent out on July 20, 2011 to the affected consignees with the above instructions. *****RECALL EXPANDED***** Product 2. Teleflex sent an URGENT MEDICAL DEVICE RECALL NOTIFICATION letter dated July 20, 2011, to all affected customers. The letter identified the product, the problem, and the action needed to be taken by the customer. On July 19, 2011 this recall was expanded to include additional product. Please see above strategy information for details

Recalling firm

Firm: Teleflex Medical
Address: 4024 Stirrup Creek Dr, Durham, North Carolina 27703-9000

Distribution

Distribution pattern: Nationwide Distribution: AZ, CA, FL, GA, IL, KS, KY, LA, MA, MS, NC, NJ, NM, NY, OH, OK, PA, TN, TX, VA, WI including Puerto Rico.

Timeline

Recall initiated: 2011-06-02
Posted by FDA: 2011-06-27
Terminated: 2013-04-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #100736. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.