BEUDAMED
    FDA Enforcement Class II Ongoing

    DISP.TROCAR W. DILATING PIN 10/110MM, Product Code EK224SU. For use in laparoscopic procedures.

    Recall: Z-1243-2024 · Reported March 13, 2024

    Enforcement

    Recall Number
    Z-1243-2024
    Event ID
    93856
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Aesculap Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 13, 2024
    Initiation Date
    January 9, 2024
    Classification Date
    March 1, 2024
    Address
    3773 Corporate Pkwy, Center Valley, PA, 18034-8217, United States

    Description

    DISP.TROCAR W. DILATING PIN 10/110MM, Product Code EK224SU. For use in laparoscopic procedures.

    Reason

    The sterile blister packaging may be damaged, and sterility may be compromised.

    Code Info

    Product Code: EK224SU; UDI/DI: 04046963620424; Batch Numbers (Expiration Date): 52658689 (12/08/2023), 52625350 (07/31/2025), 52567841 (11/30/2024);

    Distribution

    Worldwide - US Nationwide distribution in the states of KS, NJ and NY. The country of Canada.

    Quantity

    12 pieces