BEUDAMED
    FDA Recall Terminated

    Zimmer Hemovac Wound Drainage Device Infection Control Kits, Catalog Number; 47-2550-002-10, 400 ml evacuators and 450 ml collection bags, 1/8 in. (10 FR.) O.D. middle perforated PVC drains with trocars, evaluator tubing and connectors, medium, contains 10, non-sterile, latex free, Zimmer, Dover, Ohio;

    Recall: Z-1456-2008 · Initiated January 31, 2008

    Recall

    Recall Number
    Z-1456-2008
    Event Number
    46792
    Firm
    Zimmer Inc.
    FEI Number
    1000220733
    Product Code
    GCY
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    January 31, 2008
    Posted
    April 9, 2008
    Terminated
    November 12, 2009
    Address
    345 E Main St, Warsaw, IN, 46580-2746

    Description

    Zimmer Hemovac Wound Drainage Device Infection Control Kits, Catalog Number; 47-2550-002-10, 400 ml evacuators and 450 ml collection bags, 1/8 in. (10 FR.) O.D. middle perforated PVC drains with trocars, evaluator tubing and connectors, medium, contains 10, non-sterile, latex free, Zimmer, Dover, Ohio;

    Reason

    Leakage; The kits may disassemble at the fluid collection port, which would present a risk of exposure to blood borne pathogens to health care providers should it occur during use.

    Action

    Consignees were notified via Urgent Infection Control Recall letter dated 1/31/08 to examine their inventory and return the recalled lots. Custom kit packers were instructed in the same letter to recall these products/lots from their own customers.

    Distribution

    Worldwide-USA, Australia, Canada, Colombia, Denmark, Dubai, Italy, Japan, Mexico and Singapore.

    Quantity

    34,354 (Recalls Z-1448/1458-2008)