BEUDAMED
    FDA Recall Terminated

    CRITIFLO(tm) FLUSH KIT

    Recall: Z-0075-06 · Initiated July 1, 2005

    Recall

    Recall Number
    Z-0075-06
    Event Number
    33316
    Firm
    Becton Dickinson Medical Systems
    FEI Number
    1710034
    Product Code
    KRA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 1, 2005
    Posted
    October 21, 2005
    Terminated
    August 9, 2011
    Address
    9450 S State St, Sandy, UT, 84070-3213

    Description

    CRITIFLO(tm) FLUSH KIT

    Reason

    Device could permit an over-infusion of IV solutions during pressure monitoring procedures.

    Action

    Consignees were notified by letter on 8/22/2005 and told to immediately locate and quarantine all affected product for return to BD. Customer Recall Response Card was to completed and returned. For questions concerning the recall, call 800-453-4538 between 8AM and 5PM MST.

    Distribution

    Nationwide, including PR. VA facilities in OH, WA, NV and NY. No military or foreign distribution by US firm..

    Quantity

    250 units