AMSORB PLUS PREFILLED G-CAN 1.0L; Carbon dioxide absorbent canister; Product codes AMAB3801 and AMAB3801GE. Used in anesthesia.
Reported: September 22, 2021 Initiated: August 5, 2021 #Z-2433-2021
Product Description
AMSORB PLUS PREFILLED G-CAN 1.0L; Carbon dioxide absorbent canister; Product codes AMAB3801 and AMAB3801GE. Used in anesthesia.
Reason for Recall
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.
Details
- Recalling Firm
- Armstrong Medical Services Limited
- Units Affected
- 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.
- Location
- Coleraine, N/A
Frequently Asked Questions
What product was recalled? ▼
AMSORB PLUS PREFILLED G-CAN 1.0L; Carbon dioxide absorbent canister; Product codes AMAB3801 and AMAB3801GE. Used in anesthesia.. Recalled by Armstrong Medical Services Limited. Units affected: 214,032 boxes.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 22, 2021. Severity: Critical. Recall number: Z-2433-2021.
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