BEUDAMED
    FDA Recall Terminated

    Autovac TL. Autotransfusion System for Orthopedic Wound Drainage. The product is shipped in cartons containing 6 units

    Recall: Z-0227-04 · Initiated November 7, 2003

    Recall

    Recall Number
    Z-0227-04
    Event Number
    27721
    Firm
    Boehringer Laboratories Inc
    FEI Number
    2518417
    Product Code
    CAC
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 7, 2003
    Posted
    December 17, 2003
    Terminated
    January 20, 2004
    Address
    500 E Washington St, Norristown, PA, 19401-5149

    Description

    Autovac TL. Autotransfusion System for Orthopedic Wound Drainage. The product is shipped in cartons containing 6 units

    Reason

    Inadequate bond where the tube attaches to the inlet of the bulb.

    Action

    On 11/7/03, the recalling firm contact each account via visit by field representative. The representative informed the account of the problem and removed the product.

    Distribution

    The product was shipped to hospitals/medical centers in CT, IL, MD, MI, MS, NY, OK, PA, TN, and WA.

    Quantity

    273 units