Device product
DISP.TROCAR W. DILATING PIN 10/110MM, Product Code EK224SU. For use in laparoscopic procedures.
Z-1243-2024
Product summary
- Firm
- Aesculap Inc
- Event
- Event 93856
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 12 pieces
- Official record key
device-enforcement:Z-1243-2024
Official wording
Reason: The sterile blister packaging may be damaged, and sterility may be compromised.
Code information: Product Code: EK224SU; UDI/DI: 04046963620424; Batch Numbers (Expiration Date): 52658689 (12/08/2023), 52625350 (07/31/2025), 52567841 (11/30/2024);
Distribution pattern: Worldwide - US Nationwide distribution in the states of KS, NJ and NY. The country of Canada.
Derived failure modes
-
Sterility assurance
sterility may be compromised