Alaris PCA Module
Medical device recall Z-3139-2024. 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
- 10460 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 PCA Module Model 8120, a modular infusion pump and monitoring system
10460, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Model Number: 8120 UDI-DI codes: 10885403516030, 10885403515316, 10885403812033, 10885403812026, 10885403494291, 10885403812002 Serial Numbers: 16473112 16474187 16458453 16458381 16458632 16472825 16456729 16457626 16453240 16458585…
Every code shown here, 1,998 characters
Model Number: 8120 UDI-DI codes: 10885403516030, 10885403515316, 10885403812033, 10885403812026, 10885403494291, 10885403812002 Serial Numbers: 16473112 16474187 16458453 16458381 16458632 16472825 16456729 16457626 16453240 16458585 16450364 16459191 16458699 16473046 16458427 16473677 16472463 16459701 16472829 16458736 16458700 16457828 16460132 16455368 16472831 16473116 16457873 16460396 16473618 16473688 16458544 16458121 16473391 16527718 16527910 16441259 16441394 16528387 16441214 16477919 16441048 16525578 16440759 16441453 16525916 16441034 16441160 16441164 16450345 16441601 16454386 16442620 16479558 16452454 16358256 16452960 16453953 16452089 16472866 16452442 16449483 16282569 16452076 16473123 16453256 16448217 16452996 16438128 16453852 16282541 16453263 16453423 16454448 16452576 16450489 16453424 16453702 16453853 16452088 16452445 16453527 16298268 16454345 16282360 16452394 16280503 16452485 16298349 16440752 16441277 16453848 16451983 16453700 16454300 16453421 16438875 16452129 16453535 16452508 16472830 16472480 16442014 16282559 16441295 16450415 16450090 16452417 16471744 16452387 16453522 16453579 16452626 16452536 16282579 16441545 16472995 16282616 16438173 16449362 16449280 16449336 16527580 16441101 16525189 16526900 16526177 16511913 16441474 16515632 16441290 16527326 16440746 16440745 16283136 16284350 16284295 16278278 16282406 16282701 16284376 16284539 16285656 16283024 16285385 16280047 16282941 16282871 16284654 16285713 16280325 16284548 16282671 16284131 16282990 16282603 16285595 16280391 16285788 16285305 16284591 16285009 16280279 16283279 16284313 16285063 16282546 16283207 16282639 16282557 16283012 16284466 16279819 16283281 16282407 16282805 16282548 16284794 16285661 16283272 16282566 16285657 16284238 16285665 16285617 16279174 16283177 16283230 16285241 16282586 16280036 16280501 16284709 16284608 16285706 16285658 16285662 16282640 16282259 16282680 16284959 16284777 16285378 16285693 16279615 16284070 16282678…
FDA’s list runs to 94,285 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 94,285 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.