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Open, Classified

DISP.TROCAR W. DILATING PIN 10/110MM, Product Code EK224SU. For use in laparoscopic procedures.

FDA Recall Z-1243-2024 · Posted 2024-03-01

Recalling FirmAesculap Inc
Recall StatusOpen, Classified
Product CodeGCJ
Date Initiated2024-01-09
Product Quantity12 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.

K101937HYBRID TROCAR SYSTEMAesculap, Inc. · 2010-08-11

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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