BEUDAMED
    FDA Enforcement Class II Terminated

    Amerigel Wound Dressing 1 oz. tube

    Recall: Z-1992-2014 · Reported July 16, 2014

    Enforcement

    Recall Number
    Z-1992-2014
    Event ID
    68488
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Kova Laboratories, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    July 16, 2014
    Initiation Date
    March 21, 2014
    Classification Date
    July 4, 2014
    Termination Date
    September 12, 2016
    Address
    1711 Banks Rd, Margate, FL, 33063-7744, United States

    Description

    Amerigel Wound Dressing 1 oz. tube

    Reason

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

    Code Info

    Lot #3WD02, Lot #3WD03, Lot #3WD04 and Lot #3WD05.

    Distribution

    Distributed in the states of FL and NJ.

    Quantity

    122,396 / 1oz. tubes