BEUDAMED
    FDA Recall Terminated

    STOPCOCK EXT. SET W/ 3-WAY STOPCOCK WITH INJ. SITE AND SPINLOCK CONNECTOR, 22 inches and 37 inches

    Recall: Z-2022-2014 · Initiated May 29, 2014

    Recall

    Recall Number
    Z-2022-2014
    Event Number
    68546
    Firm
    B. Braun Medical, Inc.
    FEI Number
    2523676
    Product Code
    FPA
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    May 29, 2014
    Posted
    July 9, 2014
    Terminated
    December 10, 2014
    Address
    901 Marcon Blvd, Allentown, PA, 18109-9512

    Description

    STOPCOCK EXT. SET W/ 3-WAY STOPCOCK WITH INJ. SITE AND SPINLOCK CONNECTOR, 22 inches and 37 inches

    Reason

    Complaints were received that reported the stopcock of some Stopcock Extension Sets are assembled in the reverse position, resulting in the stopcock being closed when set in the open position and vise versa.

    Action

    An urgent medical device correction notification, dated June 3, 2014, describing the product, problem, and actions to be taken, was sent to end users and distributors.

    Distribution

    USA (nationwide) including the states of PA, IL, NC, FL, IL, CA, CO, NE, LA, NC, LA, VA, TN, NE, TX, and KS.

    Quantity

    10,835