Alaris System PC Unit
Medical device recall Z-3138-2024. 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
- 125017 device (finished devices and kits) 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 System PC Unit Model 8015 - a modular infusion pump and monitoring system
125017 device (finished devices and kits), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Model Number: 8015 UDI-DI codes: 10885403516023, 10885403515231, 10885403801549, 10885403801532, 10885403801518, 10885403519284, 10885403519215 Serial Numbers: 16405753 16405872 16376937 16389635 16405929 16385933 16392029 16405859…
Every code shown here, 1,996 characters
Model Number: 8015 UDI-DI codes: 10885403516023, 10885403515231, 10885403801549, 10885403801532, 10885403801518, 10885403519284, 10885403519215 Serial Numbers: 16405753 16405872 16376937 16389635 16405929 16385933 16392029 16405859 16355147 16385733 16356177 16358090 16405681 16405365 16391644 16365407 16380736 16406383 16370288 16342333 16406520 16340432 16406486 16342209 16339360 16356089 16379852 16406293 16365679 16343510 16340086 16394051 16372192 16406547 16392519 16342393 16370109 16378495 16380421 16406296 16366356 16406474 16376814 16333959 16390881 16355769 16405567 16405941 16380737 16406213 16391082 16405988 16340999 16334088 16370963 16405969 16406245 16406332 16406224 16386484 16406461 16394270 16406295 16381987 16405986 16337357 16405861 16373958 16388828 16406482 16377465 16406473 16378711 16343560 16388488 16384288 16342306 16342387 16355791 16366771 16406518 16398407 16392150 16339100 16339855 16385755 16386553 16360664 16394173 16406317 16388663 16389674 16406471 16390470 16402464 16341647 16365652 16405580 16343049 16390351 16365011 16406536 16406484 16357255 16344098 16405945 16405623 16340058 16381253 16398304 16406479 16405601 16392485 16406540 16374550 16339803 16406524 16377605 16372148 16406514 16406539 16340891 16406457 16339474 16370175 16340358 16406543 16369665 16366663 16341788 16380626 16406511 16406502 16406519 16400608 16405768 16406552 16406517 16405448 16203194 16202076 16202216 16202221 16203212 16202062 16203196 16202042 16203116 16203187 16202205 16203083 16203208 16203198 16202983 16203185 16203120 16202120 16203152 16203200 16203146 16203125 16203149 16203081 16192323 16192072 16192120 16192208 16376983 16358358 16358871 16431754 16344417 16432467 16431907 16507863 16433198 16432477 16433311 16506147 16345129 16433053 16433227 16490382 16431647 16508003 16508095 16506196 16432231 16344327 16431706 16346301 16344250 16506376 16505293 16431887 16504733 16502286 16343587 16467604 16506192 16508094 16508165 16343705 16432864…
FDA’s list runs to 1,125,346 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 1,125,346 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.