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

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.

On August 5, 2021, the firm emailed Urgent Medical Device Correction letters to impacted customers. Users are requested to review the list of potentially affected devices and return the completed response form to Armstrong Medical or to an appointed distributor to receive replacement units. Where users have opted to temporarily retain their stock of potentially affected devices, those users are asked to ensure that the revised pre-use test in the letter is always completed prior to use. The letter included instructions to check that the ventilator functions correctly, to be performed in supplement to the <> test before each patient. Customers may contact the recalling firm at [email protected].