BEUDAMED
    FDA Enforcement Class II Terminated

    Ultrasound USB needles, with 30 degree bevel, packaged individually, 10 needles/box, item number REF USB050-22. Needles for peripheral nerve blocking under ultrasound guidance

    Recall: Z-1609-2014 · Reported May 21, 2014

    Enforcement

    Recall Number
    Z-1609-2014
    Event ID
    68026
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    RM Temena GmbH
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 21, 2014
    Initiation Date
    March 19, 2014
    Classification Date
    May 12, 2014
    Termination Date
    September 19, 2016
    Address
    Mittelhoefer Str. 1, D-34587, Felsberg, N/A, Germany

    Description

    Ultrasound USB needles, with 30 degree bevel, packaged individually, 10 needles/box, item number REF USB050-22. Needles for peripheral nerve blocking under ultrasound guidance

    Reason

    Ultrasound needles may be defective and leak at the needle hub.

    Code Info

    Lot B3070012 EXP 2018-02-28 Lot B3250001 EXP 2018-06-30 Lot B3250026 EXP 2018-06-30

    Distribution

    US Distribution including the states of MD and IL.

    Quantity

    7370 needles