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

Recalled March 15, 2017 · FDA recall Z-1409-2017 · Covidien

Hazard

Sterility compromised due to breach in sterile barrier · FDA Class II

Units

42,750 units

Sold at

Nationwide

Description

Sterility compromised due to breach in sterile barrier

Product

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

Manufacturer(s)

Covidien LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →