RecallDepth

DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK236SU. For use in laparoscopic procedures.

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

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.

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