DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK234SU. For use in laparoscopic procedures.
FDA Recall Z-1245-2024 · Posted 2024-03-01
Recalling FirmAesculap Inc
Recall StatusOpen, Classified
Product CodeGCJ
Date Initiated2024-01-09
Product Quantity6 pieces
Reason for Recall
The sterile blister packaging may be damaged, and sterility may be compromised.
Firm 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.
Root Cause
Packaging change control
Distribution Pattern
Worldwide - US Nationwide distribution in the states of KS, NJ and NY. The country of Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.