Recall Z-1246-2024
Aesculap Inc · initiated January 9, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK236SU. For use in laparoscopic procedures.
Codes / lots: Product Code: EK236SU; UDI/DI: 04046963620479; Batch Numbers (Expiration Date): 52580815 (12/08/2023);
Reason for recall
The sterile blister packaging may be damaged, and sterility may be compromised.
FDA-determined cause: Packaging change control
Action taken
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.
Details
- Recall number
- Z-1246-2024
- Initiated
- January 9, 2024
- Posted by FDA
- March 1, 2024
- Product code
- GCJ – Laparoscope, General & Plastic Surgery
- Quantity
- 6 pieces
- Distribution
- Worldwide - US Nationwide distribution in the states of KS, NJ and NY. The country of Canada.
- Recalling firm
- Aesculap Inc, Center Valley, PA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1243-2024 Class II | DISP.TROCAR W. DILATING PIN 10/110MM, Product Code EK224SU. For use in laparoscopic…The sterile blister packaging may be damaged, and sterility may be compromised. | 01/09/2024Open, Classified |
| Z-1244-2024 Class II | DISP.HASSON TROCAR 10/110MM, Product Code EK230SU. For use in laparoscopic procedures.The sterile blister packaging may be damaged, and sterility may be compromised. | 01/09/2024Open, Classified |
| Z-1245-2024 Class II | DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK234SU. For use in laparoscopic…The sterile blister packaging may be damaged, and sterility may be compromised. | 01/09/2024Open, Classified |
| Z-1247-2024 Class II | DISP.HASSON TROCAR 12/110MM, Product Code EK240SU. For use in laparoscopic procedures.The sterile blister packaging may be damaged, and sterility may be compromised. | 01/09/2024Open, Classified |