Device product
DISP.HASSON TROCAR 10/110MM, Product Code EK230SU. For use in laparoscopic procedures.
Z-1244-2024
Product summary
- Firm
- Aesculap Inc
- Event
- Event 93856
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 18 pieces
- Official record key
device-enforcement:Z-1244-2024
Official wording
Reason: The sterile blister packaging may be damaged, and sterility may be compromised.
Code information: Product Code: EK230SU; UDI/DI: 04046963620455; Batch Numbers (Expiration Date): 52481826 (02/29/2024), 52644661 (02/28/2026);
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