BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1797-2015 · Initiated February 25, 2015

    Recall

    Recall Number
    Z-1797-2015
    Event Number
    71161
    Firm
    Amerx Health Care Corp.
    FEI Number
    1000525408
    Product Code
    MGQ
    Status
    Terminated
    Root Cause
    Labeling False and Misleading
    Initiated
    February 25, 2015
    Posted
    June 12, 2015
    Terminated
    October 3, 2016
    Address
    1300 S. Highland Avenue, Clearwater, FL, 33756

    Description

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

    Reason

    Nonapproved labeling claims (Sterile)

    Action

    On March 9, 2015 the firm contacted its customers via telephone. Within that conversation the firm asked its customers to examine their inventory to determine if they have any of the affected lot numbers on hand and notify the firm for an immediate product substitution, credit or refund. Customers were asked to discontinue dispensing any product on hand, and notify any customers that the product may have been further distributed to. The firm also asked that the response form be completed and returned. If no contact was made via telephone, the firm sent a certified letter asking the firm(s) to do the same actions as the phone request. If you have any questions please call 1-800-448-9599 or e-mail [email protected].

    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