BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-1243-2024 · Initiated January 9, 2024

    Recall

    Recall Number
    Z-1243-2024
    Event Number
    93856
    Firm
    Aesculap Inc
    FEI Number
    2916714
    Product Code
    GCJ
    Status
    Open, Classified
    Root Cause
    Packaging change control
    Initiated
    January 9, 2024
    Posted
    March 1, 2024
    Address
    3773 Corporate Pkwy, Center Valley, PA, 18034-8217

    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.

    Action

    URGENT MEDICAL DEVICE RECALL NOTIFICATION letters dated January 5, 2024 were sent to customers. Customers were instructed to cease use and quarantine all product subject to recall. Once Aesculap Customer Support receives the customer's acknowledgement form, they will contact the customer to arrange for credit and to have the current inventory returned.

    Distribution

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

    Quantity

    12 pieces