BEUDAMED
    FDA Enforcement Class II Terminated

    Affected Pain Control Tray Component (5% Lidocaine Hydrochloride and 7.5% DExtrose Injection, USP) Injection of anesthetics to provide regional anesthesia

    Recall: Z-0327-2017 · Reported November 9, 2016

    Enforcement

    Recall Number
    Z-0327-2017
    Event ID
    74879
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    B. Braun Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 9, 2016
    Initiation Date
    July 11, 2016
    Classification Date
    November 1, 2016
    Termination Date
    March 15, 2017
    Address
    901 Marcon Blvd, Allentown, PA, 18109-9512, United States

    Description

    Affected Pain Control Tray Component (5% Lidocaine Hydrochloride and 7.5% DExtrose Injection, USP) Injection of anesthetics to provide regional anesthesia

    Reason

    B. Braun Medical Inc. is voluntarily recalling specific lots of their Custom Spinal Anesthesia Tray which contains a drug component, 5% Lidocaine Hydrochloride and 7.5 % Dextrose Injection, USP that Hospira Inc. has recalled because the drug product does not meet the specification for color throughout shelf life.

    Code Info

    Catalog Number: 560399 (Lot # 0061418559, 0061422389, 0061434523, 0061438084, 0061440188, 0061446168, 0061450971, 0061459227, 0061464239, Catalog Number: 560511 (Lot # 0061413435, 0061425996, 0061438393, 0061452272, 0061465310), Catalog # 560605 (0061420240, 0061429962, 0061442280, 0061449510, 0061460497, 0061471580), Catalog # 560631 (Lot# 0061438803), Catalog # 560632 (0061438818).

    Distribution

    US Distribution to: AL, IL, OK, MN, MA and WI.

    Quantity

    1704 units