BEUDAMED
    FDA Recall Terminated

    Organogenesis Apligraf, interactive wound and burn dressing, Organogenesis, Inc., Canton, Massachusetts 02021

    Recall: Z-0675-2008 · Initiated December 26, 2007

    Recall

    Recall Number
    Z-0675-2008
    Event Number
    46250
    Firm
    Organogenesis, Inc.
    FEI Number
    1000148471
    Product Code
    MGR
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    December 26, 2007
    Posted
    January 24, 2008
    Terminated
    May 15, 2015
    Address
    150 Dan Road, Canton, MA, 02021-2820

    Description

    Organogenesis Apligraf, interactive wound and burn dressing, Organogenesis, Inc., Canton, Massachusetts 02021

    Reason

    Contamination: Apligraf units were reported to have contamination in the agarose nutrient medium of some units retained at Organogenesis. Preliminary tests show a gram negative rod (bacillus) organism.

    Action

    On 12/26/07, Organogenesis began to telephone the consignees to inform them of the recall. The firm sent a follow-up fax on 12/31/07 to all treating physicians who applied the product requesting patient status information. The Dear Doctor letter, dated December 27, 2007, was titled, "Subject: Potential contaminated Apligraf Units manufactured by Organogenesis, Inc." Consignees were instructed to return unused product, and monitor patients who received the Apligraf for adverse events.

    Distribution

    Nationwide Distribution.

    Quantity

    177 units