DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK236SU. For use in laparoscopic procedures.
This recall is currently active, issued March 1, 2024. It was issued by Aesculap Inc.
- Company
- Aesculap Inc
- Recall Initiated
- January 9, 2024
- Posted
- March 1, 2024
- Recall Number
- Z-1246-2024
- Quantity
- 6 pieces
- Firm Location
- Center Valley, PA
- Official Source
- View on FDA website ↗
Reason for Recall
The sterile blister packaging may be damaged, and sterility may be compromised.
Distribution
Worldwide - US Nationwide distribution in the states of KS, NJ and NY. The country of Canada.
Lot / Code Info
Product Code: EK236SU; UDI/DI: 04046963620479; Batch Numbers (Expiration Date): 52580815 (12/08/2023);
Root 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.