AMSORB PLUS PREFILLED G-CAN 1.0L
Medical device recall Z-2433-2021. Published in FDA’s Enforcement Report on Sep 22, 2021.
- FDA Class I
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Sep 22, 2021. Copied from openFDA on Oct 20, 2026.
- Class I FDA’s most serious class (needs attention)
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 214,032 boxes how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class I, the most serious of FDA’s three classes.
“Dangerous or defective products that predictably could cause serious health problems or death. Examples include: food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.”
openFDA, in plain words, its enforcement report fields.
“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.”
FDA’s rule, 21 CFR 7.3(m)(1), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
AMSORB PLUS PREFILLED G-CAN 1.0L; Carbon dioxide absorbent canister; Product codes AMAB3801 and AMAB3801GE. Used in anesthesia.
214,032 boxes, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
LOTS 010321F51 010421F11 010421F111 010621F11 010621F111 010920F61 010920F611 011020F21 011020F211 011220F414 020621F21 020621F211 020920F11 020920F111 020920F112 020920F113 030621F41 030621F411 030820F51 030820F511 030820F512 030820F513…
Every code shown here, 1,933 characters
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
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Aug 5, 2021.
- FDA classified it on Sep 13, 2021.
- FDA’s Enforcement Report published it on Sep 22, 2021.
- FDA terminated it on Sep 17, 2024.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Armstrong Medical Services Limited, of Coleraine, Ireland.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: E-Mail.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.