FDA-Device2017-03-15Class II
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
Covidien LLC
Hazard
Sterility compromised due to breach in sterile barrier
Sold states
Nationwide
Affected count
1,111,600 units
Manufactured in
60 Middletown Ave, N/A, North Haven, CT, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1408-2017Don't want to check this manually?
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