BEUDAMED
    FDA Enforcement Class III Terminated

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

    Recall: Z-2154-2014 · Reported August 13, 2014

    Enforcement

    Recall Number
    Z-2154-2014
    Event ID
    68746
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Teleflex Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 13, 2014
    Initiation Date
    July 10, 2014
    Classification Date
    August 6, 2014
    Termination Date
    November 25, 2015
    Address
    4024 Stirrup Creek Dr, N/A, Durham, NC, 27703-9000, United States

    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.

    Code Info

    Product Code: 76730, Lot number: 307505.

    Distribution

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

    Quantity

    720