Recall Z-2433-2021 ยท CBL Absorbent, Carbon-Dioxide
Armstrong Medical Services Limited
AMSORB PLUS PREFILLED G-CAN 1.0L; Carbon dioxide absorbent canister; Product codes AMAB3801 and AMAB3801GE. Used in anesthesia.
| Date | Sep 13, 2021 (initiated Aug 5, 2021) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | On August 5, 2021, the firm emailed Urgent Medical Device Correction letters to impacted customers. Users are requested to review the list of potentially affected devices and return the completed response form to Armstrong Medical or to an appointed distributor to receive replacement units. Where users have opted to temporarily retain their stock of potentially affected devices, those users are asked to ensure that the revised pre-use test in the letter is always completed prior to use. The letter included instructions to check that the ventilator functions correctly, to be performed in su |
| Quantity | 214,032 boxes |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.