BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-0774-2023 · Initiated November 8, 2022

    Recall

    Recall Number
    Z-0774-2023
    Event Number
    91236
    Firm
    ENDO Pharmaceuticals Solutions, Inc.
    FEI Number
    2243842
    Product Code
    MDM
    Status
    Open, Classified
    Root Cause
    Incorrect or no expiration date
    Initiated
    November 8, 2022
    Posted
    December 30, 2022
    Address
    8 Clarke Dr, Cranbury, NJ, 08512-3617

    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

    Action

    Endo Pharmaceuticals issued Medical Device Market Withdrawal letter dated 12/8/22 to Distributor and End-Users via email/mail. Letter states reason for recall, health risk and action to take: 1. If you have any affected lots in your inventory, please immediately quarantine to prevent any further use. 2. Please complete the Market Withdrawal Acknowledgement and Receipt Form (attached below)and email to [email protected] or return by fax to 1-610-561-3085. 3. A shipping label will be mailed to the address provided on the Market Withdrawal Acknowledgement and Receipt form and any affected devices along with the completed form are returned to: Endo Pharmaceuticals 8 Clarke Dr., Suite 6 Cranbury, NJ 08512 Attn: Trocar Market Withdrawal Returned product will be replaced by Endo Pharmaceuticals Inc. Customers who have questions or need additional information regarding this correction may contact Endo at 1-800-462-3636. If you have further distributed this product, please identify and notify your customers of this product recall. Please ensure that this notification is forwarded to all Healthcare Professionals who have received the 9 Gauge Disposable Trocars with Blunt Pushers for Use with Subcutaneous Implants from the lots identified in Table 1 (page 3 of 5). Please let end users know to return for replacement . November 8, 2022 Endo notified the wholesaler to prevent any further distribution of the affected lots.

    Distribution

    Nationwide

    Quantity

    2603 units