BEUDAMED
    FDA Enforcement Class II Terminated

    Amerigel Hydrogel Gauze Dressing 2 x 2, A5002. Wound Management.

    Recall: Z-1797-2015 · Reported June 24, 2015

    Enforcement

    Recall Number
    Z-1797-2015
    Event ID
    71161
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Amerx Health Care Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 24, 2015
    Initiation Date
    February 25, 2015
    Classification Date
    June 12, 2015
    Termination Date
    October 3, 2016
    Address
    1300 S. Highland Avenue, Clearwater, FL, 33756, United States

    Description

    Amerigel Hydrogel Gauze Dressing 2 x 2, A5002. Wound Management.

    Reason

    Nonapproved labeling claims (Sterile)

    Code Info

    ALL Lots - 11406, 11414, 12439, 12466, and 02521.

    Distribution

    Worldwide Distribution -- US, including the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WV, WY and Hawaii; and, the countries of Canada and Bahrain.

    Quantity

    6,491 units