BEUDAMED
    FDA Recall Terminated

    Amerigel Wound Dressing Maximum Strength CAT# A2001. Wound management.

    Recall: Z-2638-2014 · Initiated July 11, 2014

    Recall

    Recall Number
    Z-2638-2014
    Event Number
    69083
    Firm
    Amerx Health Care Corp.
    FEI Number
    1000525408
    Product Code
    MGQ
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    July 11, 2014
    Posted
    September 12, 2014
    Terminated
    July 22, 2015
    Address
    1300 S. Highland Avenue, Clearwater, FL, 33756

    Description

    Amerigel Wound Dressing Maximum Strength CAT# A2001. Wound management.

    Reason

    Not approved labeling claims (antimicrobial and autolytic debridement)

    Action

    On July 21, 2014, Amerx Health Care Corporation telephoned all affected customers advising them of the recalled products. During the call the customers were instructed to: 1) Discontinue dispensing the lot(s) and promptly return via parcel post to the Clearwater facility. 2) If you dispose of the product on your own, provide proof of disposal. 3) You will be reimbursed by check or credit memo for returned or disposed goods and postage.

    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

    382,620 units