BEUDAMED
    FDA Recall Terminated

    Integra Bilayer Matrix Wound Dressing, 8 in X 10 in (20 cm x 25 cm); Non-pyrogenic, Do not Re sterilize, Store flat at room temperature, Avoid Excessive heat, Avoid freezing. Sterile. Catalog number BMW810. Integra LifeSciences Corporation, 311 Enterprise Drive, Plainsboro, NJ 08536, USA.

    Recall: Z-1174-2009 · Initiated March 10, 2009

    Recall

    Recall Number
    Z-1174-2009
    Event Number
    51402
    Firm
    Integra LifeSciences Corp.
    FEI Number
    3003418325
    Product Code
    FRO
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    March 10, 2009
    Posted
    April 7, 2009
    Terminated
    June 26, 2009
    Address
    311 Enterprise Dr, Plainsboro, NJ, 08536-3344

    Description

    Integra Bilayer Matrix Wound Dressing, 8 in X 10 in (20 cm x 25 cm); Non-pyrogenic, Do not Re sterilize, Store flat at room temperature, Avoid Excessive heat, Avoid freezing. Sterile. Catalog number BMW810. Integra LifeSciences Corporation, 311 Enterprise Drive, Plainsboro, NJ 08536, USA.

    Reason

    Package Seal Integrity: Integra became aware of the potential of open seals in the foil pouch of the Integra Bilayer Matrix Wound Dressings.

    Action

    Urgent: Product Recall Notification letters, dated March 10, 2009, were sent out by first class mail to all consignees. The letters asked consignees to quarantine any stock on hand and contact their local Integra Sales Representative for further assistance and for arrangement of product returns. Consignees also need to complete and return the "Recall Acknowledgement and Return Form" indicating whether or not they possess any affected product. Additional questions should be directed to Judith O'Grady at 609-936-2311.

    Distribution

    Nationwide Distribution -- including states of CA, FL, MN, TX, NC, GA, NY, OH, MI, NE, and PA.

    Quantity

    125 units