BEUDAMED
    FDA Enforcement Class II Terminated

    Amerigel Post-Op Surgical Kits . Kit includes: Amerigel Wound Dressing, Amerigel Wound Wash, 22x2 Gauze Pads, and 1x3 Fabric Bandages CAT # A2002. Wound management.

    Recall: Z-2640-2014 · Reported September 24, 2014

    Enforcement

    Recall Number
    Z-2640-2014
    Event ID
    69083
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Amerx Health Care Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    September 24, 2014
    Initiation Date
    July 11, 2014
    Classification Date
    September 12, 2014
    Termination Date
    July 22, 2015
    Address
    1300 S. Highland Avenue, N/A, Clearwater, FL, 33756, United States

    Description

    Amerigel Post-Op Surgical Kits . Kit includes: Amerigel Wound Dressing, Amerigel Wound Wash, 22x2 Gauze Pads, and 1x3 Fabric Bandages CAT # A2002. Wound management.

    Reason

    Not approved labeling claims (antimicrobial and autolytic debridement)

    Code Info

    Lot codes: JCA0086 through JCA0106.

    Distribution

    Worldwide Distribution-USA (nationwide) including the District of Columbia, Virgin Islands, Puerto Rico, and Guam, and the states of AK, AL, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, LA, MA, ME, MD, MI, MT, MO, NC, NH, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WY, and WV, and the countries of Canada, England, Africa, and Australia.

    Quantity

    116,633 units