BEUDAMED
    FDA Enforcement Class II Terminated

    PENCAN Spinal Anesthesia Tray. Product Catalog Number: 560590. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.

    Recall: Z-0572-2018 · Reported February 21, 2018

    Enforcement

    Recall Number
    Z-0572-2018
    Event ID
    78878
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    B. Braun Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 21, 2018
    Initiation Date
    June 21, 2017
    Classification Date
    February 9, 2018
    Termination Date
    April 3, 2018
    Address
    901 Marcon Blvd, Allentown, PA, 18109-9512, United States

    Description

    PENCAN Spinal Anesthesia Tray. Product Catalog Number: 560590. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.

    Reason

    B. Braun Medical Inc. (BBMI) initiated this recall of various BBMI convenience kits containing the 22GA 1-1/2in SafetyGlide Needle due to the presence of loose polypropylene foreign matter was above release specification. This foreign matter has been identified as a product hub material which has been tested for biocompatibility per ISO 10993 during the product development process.

    Code Info

    0061525340. 0061535836.

    Distribution

    US Nationwide Distribution.

    Quantity

    700 units