BEUDAMED
    FDA Recall Terminated

    Amerigel Hydrogel Wound Dressing Wound management

    Recall: Z-0497-2015 · Initiated September 26, 2014

    Recall

    Recall Number
    Z-0497-2015
    Event Number
    69394
    Firm
    Amerx Health Care Corp.
    FEI Number
    1000525408
    Product Code
    MGQ
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    September 26, 2014
    Posted
    December 4, 2014
    Terminated
    October 3, 2016
    Address
    1300 S. Highland Avenue, Clearwater, FL, 33756

    Description

    Amerigel Hydrogel Wound Dressing Wound management

    Reason

    Formulation deviation

    Action

    Amerx Health Care Corporation sent an URGENT: DEVICE RECALL letter instructing consignees to examine their inventory and immediately determine if they have any of the Lot numbers on hand and to quarantine the product subject to recall. In addition, if they may have further distributed the product, please notify their customers and/or post the enclosed letter in a visible location for the customer to read. Customers with questions were instructed to call 800-448-9599 or email [email protected]. For questions regarding this recall call 727-443-0530.

    Distribution

    Worldwide Distribution - US (nationwide) including states of: AK, AL, AZ, CA, CO, CT, FL, GA, IA, 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, WV, Virgin Islands, Puerto Rico, Guam, Hawaii and District of Columbia and Internationally to: Canada, England, Africa, and Australia.

    Quantity

    340,896