Alaris Pump Module
Medical device recall Z-3142-2024. 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
- 192964 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 Pump Module Model 8100, a modular infusion pump and monitoring system
192964, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Model Number: 8100 UDI-DI code: 10885403810046, 10885403810039, 10885403810015 Serial Numbers: 16448779 16451711 16451209 16450973 16450971 16451760 16407678 16411676 16388896 16405467 16408857 16387206 16405786 16407463 16410819 16407769…
Every code shown here, 1,994 characters
Model Number: 8100 UDI-DI code: 10885403810046, 10885403810039, 10885403810015 Serial Numbers: 16448779 16451711 16451209 16450973 16450971 16451760 16407678 16411676 16388896 16405467 16408857 16387206 16405786 16407463 16410819 16407769 16399159 16410420 16411470 16409931 16409006 16411571 16409107 16388799 16472492 16409660 16410466 16404846 16409933 16410968 16406453 16406013 16408309 16402653 16410415 16411500 16411069 16407539 16410537 16451801 16450922 16451705 16448898 16451601 16448918 16450847 16453708 16451857 16451608 16451642 16372116 16451808 16451067 16451690 16451895 16445957 16453760 16451083 16453750 16448376 16450498 16451078 16448899 16451051 16453718 16450801 16449025 16450557 16453778 16448576 16450674 16451410 16448921 16451745 16451356 16451907 16453721 16451788 16450769 16451819 16448338 16449113 16451236 16450609 16450928 16448781 16451823 16450969 16451794 16451840 16451856 16445998 16451321 16451787 16444660 16407683 16410698 16410619 16403032 16472342 16408257 16384862 16407887 16408415 16409022 16406455 16409686 16411724 16410412 16565972 16387963 16409990 16411378 16407898 16409960 16403700 16407660 16389103 16472045 16405794 16409501 16410040 16409063 16410492 16407922 16405757 16410823 16410875 16410360 16410960 16403230 16411134 16409981 16408763 16330176 16389104 16410530 16408195 16407470 16407516 16451525 16453706 16453685 16450810 16448629 16454181 16451518 16451924 16451683 16450580 16451470 16374696 16450837 16450974 16445414 16451618 16449185 16451580 16450851 16442339 16450878 16451817 16448878 16452497 16451578 16453712 16453723 16449014 16453761 16453716 16451827 16451762 16448501 16450869 16450750 16451633 16451780 16446661 16451640 16451656 16451803 16451777 16448664 16448869 16450651 16451804 16450602 16451816 16453689 16451900 16451929 16450936 16451850 16451641 16450819 16451620 16451809 16448315 16453731 16451077 16451782 16451076 16449143 16448926 16453695 16449026 16451852 16448886 16450673 16451659 16442380…
FDA’s list runs to 1,736,823 characters. The first part is shown; the rest is on FDA’s record.
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.”
- FDA’s list of codes runs to 1,736,823 characters; the first part is shown here, and the rest is on FDA’s record.
- 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.