FDA recall Z-2433-2021

Product

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

Reason for recall

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.

Distribution

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.

Key facts

Status

Terminated

Initiation date

2021-08-05

Report date

2021-09-22

Termination date

2024-09-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Coleraine, N/A, Ireland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2433-2021