Covidien LLC recalls Signia" Power Handle (SIGPHANDLE, SIGNVAL1 and SIGVAL20 - Kits) The Signia" Power Handle, when used with Endo GIA" sing…

Recall date

December 13, 2017

Source

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

Recall number

Z-1237-2018

FDA classification

Class II

Brand / firm

Covidien LLC

Sold / distributed

Worldwide Distribution: US (Nationwide).

Why it was recalled

Product reportedly shutting down during use.

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

What was recalled

Signia" Power Handle (SIGPHANDLE, SIGNVAL1 and SIGVAL20 - Kits) The Signia" Power Handle, when used with Endo GIA" single-use reloads and Endo GIA" single-use reloads with Tri-Staple" Technology, has applications in open and minimally invasive general abdominal, gynecological, pediatric, and thoracic surgery for resection, transection, and creation of anastomosis.