BEUDAMED
    FDA Recall Terminated

    B.Braun HyperFormer Pump Dispensing Set, Catalog Number V9900-02. The product is shipped in cases containing 10 sets.

    Recall: Z-0783-2007 · Initiated April 11, 2007

    Recall

    Recall Number
    Z-0783-2007
    Event Number
    37855
    Firm
    B. Braun Medical, Inc.
    FEI Number
    2523676
    Product Code
    LHI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 11, 2007
    Posted
    May 5, 2007
    Terminated
    August 7, 2007
    Address
    901 Marcon Boulevard, Allentown, PA, 18109-9512

    Description

    B.Braun HyperFormer Pump Dispensing Set, Catalog Number V9900-02. The product is shipped in cases containing 10 sets.

    Reason

    The integrity of the sterile product barrier may be compromised

    Action

    An Urgent Product Removal Notice was issued to the distributors on 4/11/07. The notice informs the distributors of the problem, the need to conduct a sub recall and to return the product.

    Distribution

    Nationwide distribution --- including states of GA, MA, OH, and TX

    Quantity

    180 units