BEUDAMED
    FDA Enforcement Class II Ongoing

    9 Gauge Disposable Trocars with Blunt Pushers for Use with Subcutaneous Implants Part Number: 50134-01

    Recall: Z-0774-2023 · Reported January 11, 2023

    Enforcement

    Recall Number
    Z-0774-2023
    Event ID
    91236
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    ENDO Pharmaceuticals Solutions, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 11, 2023
    Initiation Date
    November 8, 2022
    Classification Date
    December 30, 2022
    Address
    8 Clarke Dr, N/A, Cranbury, NJ, 08512-3617, United States

    Description

    9 Gauge Disposable Trocars with Blunt Pushers for Use with Subcutaneous Implants Part Number: 50134-01

    Reason

    No expiration dates printed on the packaging

    Code Info

    UDI: N/A Lot Numbers: 58672, 58673

    Distribution

    Nationwide

    Quantity

    2603 units