FDA-Device2021-09-22Class I
AMSORB PLUS PREFILLED G-CAN 1.0L; Carbon dioxide absorbent canister; Product codes AMAB3801 and AMAB3801GE. Used in anesthesia.
Armstrong Medical Services Limited
Hazard
Some devices may be associated with high and unexpected resistance to gas flow during clinical use, impacting or preventing adequate ventilation of an anaesthetised patient, which could cause a delay in treatment. Not all defective canisters will be identified by the pre-use test.
Sold states
Worldwide distribution - US Nationwide distribution and the countries of Austria, Belgium, Canada, Finland, Germany, Greece, Iceland, India, Ireland, Israel, Italy, Japan, Kuwait, Portugal, United Kingdom.
Affected count
214,032 boxes
Manufactured in
NewBridge Road, Wattstown Business Park, Coleraine, N/A, Ireland
Products
AMSORB PLUS PREFILLED G-CAN 1.0L; Carbon dioxide absorbent canister; Product codes AMAB3801 and AMAB3801GE. Used in anesthesia.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2433-2021Don't want to check this manually?
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