AMSORB PLUS PREFILLED G-CAN 1 — Class I medical device recall Z-2433-2021
Terminated recall by Armstrong Medical Services Limited, reported 2021-09-22, distributed nationwide. Some devices may be associated with high and unexpected resistance to gas flow during clinical use, impacting
| Recall number | Z-2433-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Armstrong Medical Services Limited, Coleraine, N/A, Ireland |
| Recall initiated | 2021-08-05 |
| Classified | 2021-09-13 |
| Reported by FDA | 2021-09-22 |
| Terminated | 2024-09-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BE, CA, DE, FI, GB, GR, IE, IL, IN, IS, IT, JP, KW, PT |
| Quantity | 214,032 boxes |
| Lot numbers | 010321F51, 010421F11, 010421F111, 010621F11, 010621F111, 010920F61, 010920F611, 011020F21, 011020F211, 011220F414, 020621F21, 020621F211, 020920F11, 020920F111, 020920F112, 020920F113, 030621F41, 030621F411, 030820F51, 030820F511, 030820F512, 030820F513, 040121F412, 040121F413, 040621F11, 040621F111, 040920F21, 040920F211, 040920F212, 040920F213, 050521F41, 050521F411, 050521F51, 050521F511, 050521F512, 060521F21, 060521F211, 070521F41, 070521F411, 070621F31 and 142 more |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2433-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.