Recall record at a glance
| Official record | Z-2433-2021 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class I |
| FDA record status | Terminated |
| Recalling firm | Armstrong Medical Services Limited |
| Report date | Sep 22, 2021 |
| Recall initiation date | Aug 5, 2021 |
| Quantity | 214,032 boxes |
| Location | Coleraine, N/A, Ireland |
Official product description
AMSORB PLUS PREFILLED G-CAN 1.0L; Carbon dioxide absorbent canister; Product codes AMAB3801 and AMAB3801GE. Used in anesthesia.
Why the product 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.
Distribution information
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.
How to read the classification
FDA Class I indicates a situation in which there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. The classification shown here comes directly from the FDA enforcement record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: E-Mail.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
FDA source limitation: openFDA enforcement reports are a reference dataset, not a live public-alert or recall-lifecycle service. FDA notes that enforcement-report status may not be updated after classification. Confirm current actions with the FDA, recalling firm or appropriate healthcare professional when relevant.