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U.S. Department of Health and Human Services

Class 1 Device Recall AMSORB PLUS PREFILLED GCAN 1.0L

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  Class 1 Device Recall AMSORB PLUS PREFILLED GCAN 1.0L see related information
Date Initiated by Firm August 05, 2021
Create Date September 13, 2021
Recall Status1 Open3, Classified
Recall Number Z-2433-2021
Recall Event ID 88462
Product Classification Absorbent, carbon-dioxide - Product Code CBL
Product AMSORB PLUS PREFILLED G-CAN 1.0L; Carbon dioxide absorbent canister; Product codes AMAB3801 and AMAB3801GE. Used in anesthesia.
Code Information LOTS 010321F51 010421F11 010421F111 010621F11 010621F111 010920F61 010920F611 011020F21 011020F211 011220F414 020621F21 020621F211 020920F11 020920F111 020920F112 020920F113 030621F41 030621F411 030820F51 030820F511 030820F512 030820F513 040121F412 040121F413 040621F11 040621F111 040920F21 040920F211 040920F212 040920F213 050521F41 050521F411 050521F51 050521F511 050521F512 060521F21 060521F211 070521F41 070521F411 070621F31 080121F31 080121F311 080121F312 090321F111 090321F112 090321F113 090920F31 090920F311 090920F312 090920F313 091220F51 091220F511 091220F512 100321F21 100321F211 100321F212 100521F21 100521F211 100521F212 110221F111 110321F31 110321F311 110521F31 120321F41 120321F411 120421F21 120421F211 120421F212 120521F411 120521F412 130121F11 130121F111 130121F112 130421F31 130521F51 130521F511 130521F512 141220F11 141220F111 141220F112 150221F21 150221F211 150321F51 150321F511 160221F31 160221F311 160321F11 160321F111 160421F511 160920F41 160920F411 160920F412 160920F413 170321F21 170321F211 180221F51 180221F511 180321F31 180321F311 180521F11 190121F51 190121F511 190121F512 190221F11 190221F111 190421F11 200421F41 200421F411 200421F412 210121F21 210121F211 210121F212 210421F11 210421F111 210820F31 210820F311 210820F312 210820F313 210920F51 210920F511 210920F512 210920F513 220221F21 220221F211 220321F41 220321F411 220421F21 230321F51 230321F511 230421F41 230421F411 230421F51 230421F511 240221F11 240221F111 240321F11 240321F111 240920F61 240920F611 250121F31 250121F311 250221F31 250221F311 250221F312 250221F411 250321F21 250321F211 250321F212 250820F41 250820F411 250820F412 260121F41 260121F411 260521F111 270421F312 270521F21 270521F211 270820F51 270820F511 270820F512 280421F51 280421F511 280521F31 280521F311 290121F21 290121F211 290321F31 290321F312 290421F11 290421F41 290421F411 290920F11 290920F111 290920F112 300321F41 300321F411 300421F11 300421F111 310321F51 310321F511 310521F51 310521F511
Recalling Firm/
Manufacturer		 Armstrong Medical Services Limited
NewBridge Road
Wattstown Business Park
Coleraine Ireland
For Additional Information Contact Patrick McLain
440-2870356029
Manufacturer 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.
FDA Determined
Cause 2		 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 supplement to the <> test before each patient. Customers may contact the recalling firm at Quality@armstrongmedical.net.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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