BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-2022-2014 · Reported July 16, 2014

    Enforcement

    Recall Number
    Z-2022-2014
    Event ID
    68546
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    B. Braun Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 16, 2014
    Initiation Date
    May 29, 2014
    Classification Date
    July 8, 2014
    Termination Date
    December 10, 2014
    Address
    901 Marcon Blvd, Allentown, PA, 18109-9512, United States

    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.

    Code Info

    Product codes: 473547 and 473549 lot #s and expiration dates: 61356774, 1/31/2019; 61362114, 2/28/2019; and 61367665, 3/31/2019.

    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