Armstrong Medical Services Limited recalls AMSORB PLUS PREFILLED G-CAN 1.0L; Carbon dioxide absorbent canister; Product codes AMAB3801 and AMAB3801GE. Used in ane…

Recall date

August 5, 2021

Source

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

Recall number

Z-2433-2021

FDA classification

Class I

Brand / firm

Armstrong Medical Services Limited

Sold / distributed

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.

Why it was recalled

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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

AMSORB PLUS PREFILLED G-CAN 1.0L; Carbon dioxide absorbent canister; Product codes AMAB3801 and AMAB3801GE. Used in anesthesia.