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Recall Observatory FDA recall evidence

Device product

DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK234SU. For use in laparoscopic procedures.

Z-1245-2024

January 09, 2024

Class II

Product summary

Firm
Aesculap Inc
Event
Event 93856
Status
Ongoing
Classification
Class II
Quantity
6 pieces
Official record key
device-enforcement:Z-1245-2024

Official wording

Reason: The sterile blister packaging may be damaged, and sterility may be compromised.

Code information: Product Code: EK234SU; UDI/DI: 04046963620462; Batch Numbers (Expiration Date): 52573073 (12/08/2023);

Distribution pattern: Worldwide - US Nationwide distribution in the states of KS, NJ and NY. The country of Canada.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    sterility may be compromised