BEUDAMED
    FDA Recall Terminated

    IPM Wound Gel Rx Wound Dressing IPM Wound Gel is indicated for the management of wound healing.

    Recall: Z-2112-2014 · Initiated March 25, 2014

    Recall

    Recall Number
    Z-2112-2014
    Event Number
    68556
    Firm
    Wellspring Pharmaceutical Corporation
    FEI Number
    3008139297
    Product Code
    FRO
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    March 25, 2014
    Posted
    July 29, 2014
    Terminated
    September 8, 2014
    Address
    5911 N Honore Ave, Ste 211, Sarasota, FL, 34243-2612

    Description

    IPM Wound Gel Rx Wound Dressing IPM Wound Gel is indicated for the management of wound healing.

    Reason

    Potential for microbial contamination of the product.

    Action

    WellSpring Pharmaceutical Corporation notified customers on March 25, 2014 via e-mail. The notification identified the affected product, the problem, and directed consignees to return all products.

    Distribution

    Worldwide Distribution -- USA, including the states of Alabama, Arkansas, Georgia, Illinois, Kentucky, Louisiana, Missouri, Mississippi, New Jersey, South Carolina, Tennessee, Texas, and Virginia; and the country of Canada.

    Quantity

    3,135 cartons of 4/10g tubes