BEUDAMED
    FDA Recall Terminated

    Custom Sterile Surgical Procedure Packs; Allegiance Healthcare Corporation, McGaw Park, IL 60085 USA; see code information for details. The product packaging consists of a vented polybag with a label insert inside the polybag. Catalog SOP11MEMMD, Sterile Minor Extremity Pack, Mfg date 5/20/03, Exp date 11/01/04, order 101449;

    Recall: Z-1020-03 · Initiated June 27, 2003

    Recall

    Recall Number
    Z-1020-03
    Event Number
    26609
    Firm
    Cardinal Health
    FEI Number
    3001236905
    Product Code
    LRO
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 27, 2003
    Posted
    July 24, 2003
    Terminated
    September 22, 2005
    Address
    1500 Waukegan Rd, Bldg K, Mcgaw Park, IL, 60085-6787

    Description

    Custom Sterile Surgical Procedure Packs; Allegiance Healthcare Corporation, McGaw Park, IL 60085 USA; see code information for details. The product packaging consists of a vented polybag with a label insert inside the polybag. Catalog SOP11MEMMD, Sterile Minor Extremity Pack, Mfg date 5/20/03, Exp date 11/01/04, order 101449;

    Reason

    The kits labeled as sterile were stolen in transit to the sterilizer and have not been sterilized.

    Action

    The customers who ordered the custom packs were notified of the theft of the unsterilized packs via letter dated 6/27/03, sent via Airborne Express. The accounts were requested to inspect their inventory for the affected catalog numbers and order/lot numbers, and segregate any of the product found for return and replacement.

    Distribution

    New Jersey, Tennessee, Missouri and Minnesota

    Quantity

    1242 packs total - all five kits