BEUDAMED
    FDA Recall Terminated

    Innovate Esmark Bandages, a component of various Presource Custom Sterile Packs/Presource PBDS Modules; Packaged by Cardinal Health Medical Products and services, McGaw Park, IL 60085 U.S.A.; There is no label on the Esmark bandage in the Presource pack/module, Some are placed in Tyvek pouches and some are just loose in the pack, but neither have any labeling on them. The Esmark bandage is used to support and compress a part of the patient's body. Presource Packs/Modules are manufactured, according to customer requirements, for use during surgical procedures.

    Recall: Z-1667-2011 · Initiated January 28, 2011

    Recall

    Recall Number
    Z-1667-2011
    Event Number
    57880
    Firm
    Cardinal Health
    FEI Number
    3001236905
    Product Code
    LRO
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    January 28, 2011
    Posted
    March 16, 2011
    Terminated
    September 4, 2012
    Address
    1430 Waukegan Rd, Mc Gaw Park, IL, 60085-6726

    Description

    Innovate Esmark Bandages, a component of various Presource Custom Sterile Packs/Presource PBDS Modules; Packaged by Cardinal Health Medical Products and services, McGaw Park, IL 60085 U.S.A.; There is no label on the Esmark bandage in the Presource pack/module, Some are placed in Tyvek pouches and some are just loose in the pack, but neither have any labeling on them. The Esmark bandage is used to support and compress a part of the patient's body. Presource Packs/Modules are manufactured, according to customer requirements, for use during surgical procedures.

    Reason

    Esmark bandages placed in some Presource kits/modules may not have been adequately sterilized.

    Action

    The firm, Cardinal Health, sent an "URGENT: PRODUCT RECALL" letter dated January 28, 2011 to all affected consignees/customers via UPS next day air. The letter described the product, problem and action to be taken. The customers were instructed to quarantine and return the packs/modules to Cardinal Health for destruction; contact the appropriate Customer Service group listed in the letter for return instructions, and complete and return the enclosed Acknowledgment Form via fax to 847-689-9101, regardless of whether or not they have inventory. Should you have any questions, relating to this recall, please feel free to contact Cardinal Health Quality Systems, 800-292-9332.

    Distribution

    Nationwide distribution.

    Quantity

    4.395 modules