BEUDAMED
    FDA Recall Terminated

    Engenex Wound Cover; Product Code 446470; Advanced Negative Pressure Wound Therapy System; Sterile, Box Contains 10 units. Boehringer Wound Systems, LLC, Norristown, PA 19404; Manufactured for: ConvaTec Inc., Skillman, NJ 08558. Negative Pressure Wound Therapy system is intended for the application of negative pressure to wounds to promote wound healing and for the removal of fluids including wound exudates, irrigation fluids, body fluids and infection material.

    Recall: Z-2043-2009 · Initiated July 29, 2009

    Recall

    Recall Number
    Z-2043-2009
    Event Number
    52814
    Firm
    ConvaTec
    FEI Number
    3011987967
    Product Code
    OMP
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    July 29, 2009
    Posted
    September 9, 2009
    Terminated
    October 2, 2009
    Address
    200 Headquarters Park Dr, Skillman, NJ, 08558

    Description

    Engenex Wound Cover; Product Code 446470; Advanced Negative Pressure Wound Therapy System; Sterile, Box Contains 10 units. Boehringer Wound Systems, LLC, Norristown, PA 19404; Manufactured for: ConvaTec Inc., Skillman, NJ 08558. Negative Pressure Wound Therapy system is intended for the application of negative pressure to wounds to promote wound healing and for the removal of fluids including wound exudates, irrigation fluids, body fluids and infection material.

    Reason

    Labeling: The expiration date does not appear on the product label.

    Action

    Urgent Product Recall letters dated 7/29/09, were hand delivered to all direct customers by ConvaTec Sales Reps. Customers were asked to return any unused products to their supplier. The letter also stated that a credit would be issued for the product. Customers are to contact Karen Krenta at the firm's Customer Interaction Center, 1-800-422-8811.

    Distribution

    Nationwide Distribution

    Quantity

    176 units