BEUDAMED
    FDA Recall Terminated

    Barrier Hip Sheet with Side Pockets

    Recall: Z-1137-03 · Initiated July 14, 2003

    Recall

    Recall Number
    Z-1137-03
    Event Number
    26694
    Firm
    Molnlycke Health Care Inc
    FEI Number
    2523357
    Product Code
    KKX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 14, 2003
    Posted
    August 14, 2003
    Terminated
    November 10, 2003
    Address
    826 Newtown-Yardley Road, Newton, Pa, PA, 18940

    Description

    Barrier Hip Sheet with Side Pockets

    Reason

    pouch may tear which could result in contamination of sterile field

    Action

    The recalling firm issued recall letters dated 7/9/03 to their direct accounts informing them of the problem/reason for recall, the need to return the product and to contact their customers regarding the recall.

    Distribution

    The products were shipped to distributors, hospitals, and sales representatives nationwide. The product was also shipped to dealers in Australia, New Zealand, Canada, and Belgium.

    Quantity

    2714 units