Recall Z-1246-2024— Aesculap Inc

Name: FDA recall Z-1246-2024
Creator: U.S. Food and Drug Administration
Published: 2024-01-09

Class II · Ongoing

Class II FDA medical device recall by Aesculap Inc, initiated 2024-01-09. It names one FDA 510(k) clearance: K101937. Product: DISP.TROCAR W.DILATING PIN 12/110MM, Product Code EK236SU. For use in laparoscopic procedures.. Reason: The sterile blister packaging may be damaged, and sterility may be compromised..

Recalling firm: Aesculap Inc
Classification: Class II
Status: Ongoing
Initiated: 2024-01-09
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K101937 — HYBRID TROCAR SYSTEMAesculap, Inc.·cleared 2010-08-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.