FDA-Device2017-03-15Class II
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
Covidien LLC
Hazard
Sterility compromised due to breach in sterile barrier
Sold states
Nationwide
Affected count
42,750 units
Manufactured in
60 Middletown Ave, N/A, North Haven, CT, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1409-2017Don't want to check this manually?
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