Multifire VersaTrack Auto Suture Hernia Stapler recalled over fire hazard

Recall date

May 12, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Covidien Llc recalls Multifire VersaTrack Auto Suture Hernia Stapler, 4.8mm, Part No. 174023 - Product Usage: has application in endoscopic…

Recall number

Z-2253-2020

FDA classification

Class II

Brand / firm

Covidien Llc

Sold / distributed

Worldwide distribution.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Multifire VersaTrack Auto Suture Hernia Stapler, 4.8mm, Part No. 174023 - 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).