Covidien LLC recalls Premier Guard Sterile Drape For Use with Blair-Port Wand (02-0029) and Blair-Port Wand X (01-0046) Item Number: 01-0020…

Recall date

January 23, 2017

Source

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

Recall number

Z-1408-2017

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 Sterile Drape For Use with Blair-Port Wand (02-0029) and Blair-Port Wand X (01-0046) Item Number: 01-0020 Used in conjunction RF Surgical Gauze detection systems to protect scanning device from contamination during various surgical procedures