BEUDAMED
    FDA Enforcement Class II Terminated

    Amerigel Hydrogel Wound Dressing Advanced Formula for wound management 1 oz.

    Recall: Z-2249-2016 · Reported July 27, 2016

    Enforcement

    Recall Number
    Z-2249-2016
    Event ID
    74249
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Amerx Health Care Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 27, 2016
    Initiation Date
    May 20, 2016
    Classification Date
    July 20, 2016
    Termination Date
    December 14, 2016
    Address
    1300 S Highland Ave, N/A, Clearwater, FL, 33756-6519, United States

    Description

    Amerigel Hydrogel Wound Dressing Advanced Formula for wound management 1 oz.

    Reason

    Product did not meet specifications for Zinc Acetate (OOS).

    Code Info

    Lot # 668

    Distribution

    AR, AZ, CA, CO, CT, FL, GA, IL, IN, MA, MD, MI, MO, NC, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, VA, & Alaska. Bahrain & Colombia.

    Quantity

    6,993 Units