BEUDAMED
    FDA Enforcement Class I Terminated

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

    Recall: Z-2112-2014 · Reported August 6, 2014

    Enforcement

    Recall Number
    Z-2112-2014
    Event ID
    68556
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Wellspring Pharmaceutical Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    August 6, 2014
    Initiation Date
    March 25, 2014
    Classification Date
    July 29, 2014
    Termination Date
    September 8, 2014
    Address
    5911 N Honore Ave Ste 211, Sarasota, FL, 34243-2612, United States

    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.

    Code Info

    Lot #3P3446

    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