BEUDAMED
    FDA Enforcement Class II Terminated

    BD Spinal Anesthesia Tray The BD Spinal Anesthesia Tray is intended for use by professional anesthesiologists to perform the spinal anesthesia procedure

    Recall: Z-0740-2017 · Reported December 21, 2016

    Enforcement

    Recall Number
    Z-0740-2017
    Event ID
    75802
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Becton Dickinson & Company
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 21, 2016
    Initiation Date
    November 7, 2016
    Classification Date
    December 12, 2016
    Termination Date
    September 12, 2017
    Address
    1 Becton Dr, Franklin Lakes, NJ, 07417-1815, United States

    Description

    BD Spinal Anesthesia Tray The BD Spinal Anesthesia Tray is intended for use by professional anesthesiologists to perform the spinal anesthesia procedure

    Reason

    BD is conducting a voluntary product recall of the BD Spinal Anesthesia Tray, Cat (Ref) 405671, lot B01K089D since a very low number of trays are incorrectly labeled as BD Single Shot Epidural Tray, Cat (Ref) 406069.

    Code Info

    B01K089D

    Distribution

    Nationwide Distribution

    Quantity

    4500