AMSORB PLUS Anesthesia Canisters Recalled for Gas Flow Obstruction Risk
Armstrong Medical Services Limited is recalling AMSORB PLUS PREFILLED anesthesia canisters due to risk of high resistance to gas flow that could prevent adequate ventilation. Not all defective units will be detected by standard pre-use testing.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall, which carries a minimum severity score of 4 per regulatory guidelines. Although no deaths or serious injuries are explicitly reported in the source, the hazard—high resistance to gas flow preventing adequate ventilation during anesthesia—poses significant risk of patient harm and treatment delay.
Plain-English summary
Armstrong Medical Services Limited is recalling AMSORB PLUS PREFILLED G-CAN 1.0L anesthesia canisters (product codes AMAB3801 and AMAB3801GE). Approximately 214,032 boxes have been distributed worldwide, including throughout the United States and to Austria, Belgium, Canada, Finland, Germany, Greece, Iceland, India, Ireland, Israel, Italy, Japan, Kuwait, Portugal, and the United Kingdom.
These canisters may develop high and unexpected resistance to gas flow during clinical use. This resistance can impair or prevent adequate ventilation of an anesthetized patient and could cause delays in treatment. Importantly, standard pre-use testing may not identify all defective canisters.
Healthcare facilities using AMSORB PLUS PREFILLED canisters should determine whether they have stock of the affected lot numbers and take appropriate action. Any adverse events or concerns related to this product should be reported to both the manufacturer and regulatory authorities.
The recalled product
- Product
- AMSORB PLUS PREFILLED G-CAN 1.0L; Carbon dioxide absorbent canister; Product codes AMAB3801 and AMAB3801GE. Used in anesthesia.
- Manufacturer
- Armstrong Medical Services Limited
- Affected units
- 214,032
Distribution
Distributed nationwide across the United States.
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