BEUDAMED
    FDA Recall Terminated

    Gravity and Infusion Pump Intravenous (IV) Sets using the Y-site Ultrasite Valve including: Horizon Pump IV Sets; Vista Pump IV Sets; Primary IV Sets; Blood Sets; Burette Sets; Filtered Administration Sets; Extension Sets; Anesthesia Sets; Rate Flow Extension Sets; and Rate Flow IV Administration Sets.

    Recall: Z-0933-03 · Initiated April 14, 2003

    Recall

    Recall Number
    Z-0933-03
    Event Number
    26226
    Firm
    Braun, B Medical Inc
    FEI Number
    2523676
    Product Code
    FPA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 14, 2003
    Posted
    June 12, 2003
    Terminated
    January 29, 2004
    Address
    901 Marcon Blvd, Allentown, PA, 18103

    Description

    Gravity and Infusion Pump Intravenous (IV) Sets using the Y-site Ultrasite Valve including: Horizon Pump IV Sets; Vista Pump IV Sets; Primary IV Sets; Blood Sets; Burette Sets; Filtered Administration Sets; Extension Sets; Anesthesia Sets; Rate Flow Extension Sets; and Rate Flow IV Administration Sets.

    Reason

    possible leakage

    Action

    The recalling firm sent recall letters to their direct accounts dated 4/14/03. The recall letters inform the accounts of the problem and the need to return the product.

    Distribution

    The products were shipped to medical facilities and distributors nationwide. The products were also shipped to the firm''s German facility, Canada and Spain.

    Quantity

    2577300 units