[Recalled] 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… | FDA 2021-08-05
The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.
Recall details
| Product | AMSORB PLUS PREFILLED G-CAN 1.0L; Carbon dioxide absorbent canister; Product codes AMAB3801 and AMAB3801GE. Used in anesthesia. |
|---|---|
| Brand / manufacturer | Armstrong Medical Services Limited |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-2433-2021 |
| Country of notice | Ireland |
| Risk level | Class I |
| Hazard type | recall |
| Notice date | 05 August 2021 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: 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.
This Class I recall concerns device products distributed in Ireland and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Stop using the product immediately and follow the authority's remedy (return, repair, or disposal).
Read the full official notice →
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.