Recall Z-1470-2024— Covidien, LP

Name: FDA recall Z-1470-2024
Creator: U.S. Food and Drug Administration
Published: 2024-02-28

Class II · Ongoing

Class II FDA medical device recall by Covidien, LP, initiated 2024-02-28. It names one FDA 510(k) clearance: K924011. Product: Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BT. Reason: The potential for trocar seal disengagement when using mesh products incorrectly with the device..

Recalling firm: Covidien, LP
Classification: Class II
Status: Ongoing
Initiated: 2024-02-28
Firm location: North Haven, CT, United States

510(k) clearances named in this recall

1 on FDA's record

K924011 — ORIGIN BLUNT TIP SURGICAL TROCAROrigin Medsystems, Inc.·cleared 1993-07-09

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

Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BT

Reason for recall

The potential for trocar seal disengagement when using mesh products incorrectly with the device.

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