Recall Z-1245-2024 ยท GCJ Laparoscope, General & Plastic Surgery
Aesculap Inc
DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK234SU. For use in laparoscopic procedures.
| Date | Mar 1, 2024 (initiated Jan 9, 2024) |
| Status | Open, Classified |
| Reason | The sterile blister packaging may be damaged, and sterility may be compromised. |
| Root cause | Packaging change control |
| 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. |
| Quantity | 6 pieces |
| Distribution | Worldwide - US Nationwide distribution in the states of KS, NJ and NY. The country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101937 | HYBRID TROCAR SYSTEM Aesculap, Inc., Aug 11, 2010 |