BEUDAMED
    FDA Recall Terminated

    Amerigel Wound Dressing 1 oz. tube

    Recall: Z-1992-2014 · Initiated March 21, 2014

    Recall

    Recall Number
    Z-1992-2014
    Event Number
    68488
    Firm
    Kova Laboratories, Inc.
    FEI Number
    3005050034
    Product Code
    MGQ
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    March 21, 2014
    Posted
    July 4, 2014
    Terminated
    September 12, 2016
    Address
    1711 Banks Rd, Margate, FL, 33063-7744

    Description

    Amerigel Wound Dressing 1 oz. tube

    Reason

    Product may not have been manufactured pursuant to a validated process protocol and CGMP.

    Action

    Kova Laboratories contacted customers with an URGENT: Medical Device Recall message by phone and e-mail 3/21/2014 and 4/21/2014, of the affected products to be returned.

    Distribution

    Distributed in the states of FL and NJ.

    Quantity

    122,396 / 1oz. tubes