Covidien LLC recalls Premier Guard Drape, Sterile. For Use with Verisphere (01-0035) and ArQ.Sphere (01-0044) Item Number: 01-0037 Used in c…

Recall date

January 23, 2017

Source

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

Recall number

Z-1409-2017

FDA classification

Class II

Brand / firm

Covidien LLC

Sold / distributed

Nationwide

Why it was recalled

Sterility compromised due to breach in sterile barrier

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

What was recalled

Premier Guard Drape, Sterile. For Use with Verisphere (01-0035) and ArQ.Sphere (01-0044) Item Number: 01-0037 Used in conjunction RF Surgical Gauze detection systems to protect scanning device from contamination during various surgical procedures