***** EXPANDED RECALL ***** Rusch Foley Catheter Insertion Tray with Preconnected Bag and 16 Fr. Catheter, Manufactured

FDA device recall Z-2886-2011 · posted 2011-06-27 · Terminated

Recall details

Recalling firm

Teleflex Medical

Reason for recall

Sterile integrity cannot be guaranteed.

Action taken

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

Root cause

Other

Status

Terminated

Product code

FAQ

Quantity affected

see line 1.

Distribution

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.

Date initiated

2011-06-02

Date posted

2011-06-27

Date terminated

2013-04-05

Location

Durham, NC