FDAClass IIMarch 13, 2024

Disp.trocar W.dilating PIN 12/110mm recall: Sterility Concern

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

Why was Disp.trocar W.dilating PIN 12/110mm recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK234SU. For use in laparoscopic procedures.
Recalling firm
Aesculap Inc
Quantity
6 pieces
Distribution
Worldwide - US Nationwide distribution in the states of KS, NJ and NY. The country of Canada.
Recall date
March 13, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls