BEUDAMED
    FDA Enforcement Class II Terminated

    Sprotte Spinal Tray / Sprotte Spinal Needle 24 gauge with Introducer Spinal injection of anesthetics to provide regional anesthesia

    Recall: Z-1666-2014 · Reported June 4, 2014

    Enforcement

    Recall Number
    Z-1666-2014
    Event ID
    68040
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    B. Braun Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 4, 2014
    Initiation Date
    April 3, 2014
    Classification Date
    May 28, 2014
    Termination Date
    December 2, 2014
    Address
    901 Marcon Blvd, Allentown, PA, 18109-9512, United States

    Description

    Sprotte Spinal Tray / Sprotte Spinal Needle 24 gauge with Introducer Spinal injection of anesthetics to provide regional anesthesia

    Reason

    B.Braun Medical, Inc. (BBMI) has received reports of 24 gauge Sprotte Needles that are missing the accompanying introducer needles.

    Code Info

    catalog no. 333740, lot no. 61358613, exp. 4/30/2015: Sprotte Spinal Tray, 24 gauge with 2mL Bupivacaine .75% with Dextrose 8.25% catalog no. 333741, lot no 61352071,exp. 12/31/2018: Sprotte Pencil Point Spinal Needle 24 gauge with Introducer catalog no. 333742, lot no.61350129, exp. 5/31/2015: Sprotte Spinal Tray, 24 gauge with 2mL Lidocaine 5% with Dextrose 7.5% catalog no. 560581, lot no.61354298, exp. 4/30/2015: Sprotte Spinal Tray 24 gauge with 2mL Bupivacaine .75% with Dextrose 8.25%

    Distribution

    Worldwide Distribution - USA (nationwide) and to Canada.

    Quantity

    7400