Armstrong Medical’s Anesthesia Product Recalled Due to Reduced Gas Flow
The FDA has issued on update on Armstrong Medical’s Aug. 5 recall of its Amsorb Plus Prefilled G-Can 1.0L, deeming it a Class I recall because of the risk of serious injury or death.
The recall, which was prompted by potential gas flow problems in the Amsorb canisters that may cause reduced air flow to the patient, included 214,032 units distributed from Oct. 22, 2020, to June 9, 2021.
These problems may also cause a failure in the pre-use or checkout test on the anesthesia machine when a patient is already under anesthesia, the agency said, leading to a buildup of carbon dioxide in the patient’s body.
No deaths or injuries reported for this recall so far, the FDA said.