Recall Z-2433-2021— Armstrong Medical Services Limited
Class I · Terminated
Class I FDA medical device recall by Armstrong Medical Services Limited, initiated 2021-08-05, terminated 2024-09-17. FDA's recall record names no specific 510(k) clearance for this event. Product: AMSORB PLUS PREFILLED G-CAN 1.0L; Carbon dioxide absorbent canister; Product codes AMAB3801 and AMAB3801GE. Used in anesthesia.. Reason: 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..
- Recalling firm
- Armstrong Medical Services Limited
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2021-08-05
- Terminated
- 2024-09-17
- Firm location
- Coleraine, N/A, Ireland
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.