Recall Z-2254-2020— Covidien Llc

Name: FDA recall Z-2254-2020
Creator: U.S. Food and Drug Administration
Published: 2020-05-12

Class II · Ongoing

Class II FDA medical device recall by Covidien Llc, initiated 2020-05-12. It names one FDA 510(k) clearance: K912097. Product: Multifire Endo Hernia 0 12mm Stapler with 4.8mm Disposable Loading Unit , Part No. 174025 - Product Usage: has application in endoscopic general surgery procedures for fixation of mesh in the repair of hernial defects and in other surgical specialties for approximation of tissue(s).. Reason: The product is recalled due to a manufacturing assembly error that may cause the staples to fail to properly advance within the staple cartridge when the instrument handle is compressed..

Recalling firm: Covidien Llc
Classification: Class II
Status: Ongoing
Initiated: 2020-05-12
Firm location: Mansfield, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K912097 — AUTO SUTURE ENDOSCOPIC FASCIA STAPLERUnited States Surgical, A Division of Tyco Healthc·cleared 1991-09-19

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

Multifire Endo Hernia 0 12mm Stapler with 4.8mm Disposable Loading Unit , Part No. 174025 - Product Usage: has application in endoscopic general surgery procedures for fixation of mesh in the repair of hernial defects and in other surgical specialties for approximation of tissue(s).

Reason for recall

The product is recalled due to a manufacturing assembly error that may cause the staples to fail to properly advance within the staple cartridge when the instrument handle is compressed.

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