Alaris EtCO2 Module
Medical device recall Z-0455-2016. Published in FDA’s Enforcement Report on Dec 30, 2015.
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 Dec 30, 2015. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Not named no state, in where it went
- 157 units 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 II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
CareFusion is recalling the Alaris EtCO2 module model 8300 because it may have been tested during service using a higher than specified concentration of CO2. The effect to the EtCO2 module tested with a higher concentration of CO2 could lead to an incorrect measurement of CO2.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Alaris EtCO2 Module, Model 8300. A capnograph that continuously monitors end tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2), and respiratory rate (RR).
157 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
9905776 9905792 12331254 12350410 12352410 12364342 12364343 12364901 12369088 12401328 12402583 12479923 12481239 12593721 12623833 12623957 12668253 12679872 12697242 12698542 12736367 12805782 12807757 12868325 12870021 12916518…
Every code shown here, 1,410 characters
9905776 9905792 12331254 12350410 12352410 12364342 12364343 12364901 12369088 12401328 12402583 12479923 12481239 12593721 12623833 12623957 12668253 12679872 12697242 12698542 12736367 12805782 12807757 12868325 12870021 12916518 12918611 12919079 12921157 13034011 13034375 13038124 13050300 13050648 13051034 13061112 13072829 13075412 13077962 13088823 13106029 13106030 13106138 13106140 13122164 13122401 13122402 13122936 13136786 13141565 13142603 13143660 13143809 13143889 13167255 13169672 13173261 13177210 13178248 13178389 13178391 13178512 13178968 13178969 13186760 13187737 13188106 13189792 13190670 13216601 13220274 13316434 13316444 13316453 13316473 13316496 13317481 13317552 13317553 13457448 13463929 13464899 13469917 13470004 13470021 13476713 13476912 13477643 13480785 13482441 13482518 13489475 13491251 13521218 13559325 13559686 13569291 13582129 13602388 13621652 13621847 13622337 13624519 13628251 13628876 13628877 13628918 13629153 13658756 13732201 13744088 13781347 13782359 13796475 13809762 13813539 13818275 13853185 13853375 13858182 13858798 13858976 13862567 13867168 13895850 13895989 13896107 13896108 13896110 13896347 13896456 13896669 13896747 13896748 13910604 13922145 13951711 13994625 13995332 14000190 14006401 14035430 14036040 14084571 14084629 14126982 14126990 14151686 14152555 14172846 14190913 14228679 14235981 14253982 14258801 14259542 14280651
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.
US Distribution.
These words name no state.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
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 Nov 12, 2015.
- FDA classified it on Dec 21, 2015.
- FDA’s Enforcement Report published it on Dec 30, 2015.
- FDA terminated it on Jan 23, 2017.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- CareFusion 303, Inc., of San Diego, CA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
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
-
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.