BEUDAMED
    FDA Recall Terminated

    ***** EXPANDED RECALL ***** Rusch Foley Catheter Insertion Tray with Preconnected Bag and 16 Fr. Catheter, Manufactured for and distributed by Teleflex Medical, Research Triangle Park, NC 57708 Product Usage: For one time use per the Directions for Use with urinary catheter for drainage of urine.

    Recall: Z-2886-2011 · Initiated June 2, 2011

    Recall

    Recall Number
    Z-2886-2011
    Event Number
    58966
    Firm
    Teleflex Medical
    FEI Number
    3005747797
    Product Code
    FAQ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 2, 2011
    Posted
    June 27, 2011
    Terminated
    April 5, 2013
    Address
    4024 Stirrup Creek Dr, Durham, NC, 27703-9000

    Description

    ***** EXPANDED RECALL ***** Rusch Foley Catheter Insertion Tray with Preconnected Bag and 16 Fr. Catheter, Manufactured for and distributed by Teleflex Medical, Research Triangle Park, NC 57708 Product Usage: For one time use per the Directions for Use with urinary catheter for drainage of urine.

    Reason

    Sterile integrity cannot be guaranteed.

    Action

    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

    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.

    Quantity

    see line 1.