BEUDAMED
    FDA Recall Terminated

    RUSCH Foley Urinary Catheter Insertion Tray with 10cc syringe, BZK Swabs, Sterile, Rx only, Teleflex Medical Product Code: 76730.

    Recall: Z-2154-2014 · Initiated July 10, 2014

    Recall

    Recall Number
    Z-2154-2014
    Event Number
    68746
    Firm
    Teleflex Medical
    FEI Number
    3005747797
    Product Code
    FCM
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    July 10, 2014
    Posted
    August 6, 2014
    Terminated
    November 25, 2015
    Address
    4024 Stirrup Creek Dr, Durham, NC, 27703-9000

    Description

    RUSCH Foley Urinary Catheter Insertion Tray with 10cc syringe, BZK Swabs, Sterile, Rx only, Teleflex Medical Product Code: 76730.

    Reason

    Labeling error: The manufacturing date is the same as the expiration date. The manufacturing date is correct, however the expiration date incorrectly indicates that the product is expired.

    Action

    Consignees were notified via letter on/about 07/10/2014.

    Distribution

    Nationwide distribution in CA, CT, FL, MA, MO, NJ, OH, OR and TX.

    Quantity

    720