BEUDAMED
    FDA Recall Terminated

    RUSCH, GB: Robinson/Nelaton Catheter, All Purpose PVC 40 Fr. 40 cm, Distributed by Teleflex Medical, Research Triangle Park, NC. Product Usage: Catheter that is inserted through the urethra and used to pass fluids to or from the urinary tract.

    Recall: Z-2944-2011 · Initiated June 30, 2011

    Recall

    Recall Number
    Z-2944-2011
    Event Number
    59356
    Firm
    Teleflex Medical
    FEI Number
    3005747797
    Product Code
    KOD
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 30, 2011
    Posted
    August 3, 2011
    Terminated
    April 29, 2014
    Address
    4024 Stirrup Creek Dr, Durham, NC, 27703-9000

    Description

    RUSCH, GB: Robinson/Nelaton Catheter, All Purpose PVC 40 Fr. 40 cm, Distributed by Teleflex Medical, Research Triangle Park, NC. Product Usage: Catheter that is inserted through the urethra and used to pass fluids to or from the urinary tract.

    Reason

    Pin holes were detected in the packaging therefore sterility of the device can not be guaranteed.

    Action

    Teleflex Medical sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter dated June 30, 2011 to all affected consignees. The letter described the product, problem and actions to be taken. The letter instructs the customers to discontinue use and quarantine any of the affected products. Customers were asked to complete the attached Recall Acknowledgement Form and return as per the instructions. A separate letter was sent to distributors instructing them to communicate the recall to any of their customers who may have receive the affected products, using the recall letter and form as a template. For questions, contact your local sales representative or call Customer service at 1-866-246-6990

    Distribution

    Worldwide Distribution and (USA) Nationwide Distribution.

    Quantity

    see line 1.