Alaris EtCO2 Module
Medical device recall Z-3140-2024. Published in FDA’s Enforcement Report on Sep 25, 2024.
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 25, 2024. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 51 states named
- 180 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?
Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Alaris EtCO2 Module Model 8300, a modular infusion pump and monitoring system
180, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Model Number: 8300 UDI-DI codes: 10885403830020, 10885403830013 Serial Numbers: 16233040 16233078 16233149 16233080 16233328 16233293 16233308 16233153 16233320 16192058 16233232 16233330 16226112 16196835 16233159 16233363 16233362…
Every code shown here, 1,699 characters
Model Number: 8300 UDI-DI codes: 10885403830020, 10885403830013 Serial Numbers: 16233040 16233078 16233149 16233080 16233328 16233293 16233308 16233153 16233320 16192058 16233232 16233330 16226112 16196835 16233159 16233363 16233362 16233226 16233163 16233069 16233074 16233077 16226102 16226107 16196802 16226103 16226099 16226113 16233296 16233101 16233211 16233223 16233203 16233302 16233360 16233359 16226098 16226109 16226106 16233361 16233285 16233141 16226110 16233145 16226105 16196832 16196755 16196594 16194385 16191983 16196603 16196615 16192142 16194384 16191988 16193961 16193955 16193991 16191985 16192001 16191939 16192287 16192936 16191995 16194400 16194370 16192010 16196608 16192493 16191991 16192008 16192002 16191976 16191998 16191993 16192012 16192966 16191971 16194376 16196806 16194399 16192927 16191911 16192004 16192006 16191997 16191979 16192967 16196596 16192094 16192724 16196818 16192728 16192758 16192862 16192720 16192804 16192850 16192789 16196591 16196612 16196599 16192126 16196587 16196592 16192111 16196588 16192717 16192685 16196867 16192715 16192698 16192125 16192490 16192702 16192144 16196790 16196793 16196797 16192734 16192878 16192772 16196877 16192899 16192763 16192014 16192841 16192870 16196862 16196590 16192755 16192096 16192731 16192886 16196619 16192930 16192737 16196796 16196595 16196606 16196593 16192811 16196811 16196743 16196821 16192109 16196589 16196627 16196786 16233137 16233128 16233315 16192282 16192395 16192162 16192016 16192435 16191982 16192181 16192183 16192370 16192221 16192371 16192398 16192350 16192352 16192015 16192061 16233124 16192013 16192384 16192382 16192434 16192218 16192202 16192442 16192201 16192460 16192443 16192163
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 - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, Guam, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. The countries of United Arab Emirates, Australia, Belgium, Canada, Hungary, Kuwait, Qatar, Saudi Arabia, Singapore, Taiwan, and New Zealand.
The states and territories these words name
51 states and territories.
Every one of them
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- District of Columbia
- Delaware
- Florida
- Georgia
- Guam
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Puerto Rico
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
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?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, 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 15, 2024.
- FDA classified it on Sep 13, 2024.
- FDA’s Enforcement Report published it on Sep 25, 2024.
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.