Alaris Syringe Module
Medical device recall Z-3141-2024. 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
- 20145 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 Syringe Module Model 8110, a modular infusion pump and monitoring system
20145, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Model Number: 8110 UDI-DI codes: 10885403516047, 10885403515323, 10885403811043, 10885403811036, 10885403811012, 10885403424267 Serial Numbers: 16557517 16557523 16558377 16558030 16557553 16552258 16558259 16555767 16557678 16557941…
Every code shown here, 1,998 characters
Model Number: 8110 UDI-DI codes: 10885403516047, 10885403515323, 10885403811043, 10885403811036, 10885403811012, 10885403424267 Serial Numbers: 16557517 16557523 16558377 16558030 16557553 16552258 16558259 16555767 16557678 16557941 16557706 16557760 16201478 16204104 16201486 16207089 16204181 16201491 16201552 16206906 16203916 16201484 16201546 16203885 16201616 16207145 16201496 16201611 16206327 16204189 16203959 16206827 16204092 16206937 16206843 16201523 16201556 16206381 16206138 16204129 16205794 16204207 16201166 16201493 16204172 16201517 16201564 16204027 16206473 16207211 16204173 16203733 16206915 16206904 16201480 16201489 16201498 16201623 16201481 16201163 16206319 16201540 16201528 16201156 16201479 16206787 16206311 16206911 16206331 16307400 16294280 16374263 16307376 16373254 16307505 16306734 16306695 16306293 16305549 16306102 16306495 16306346 16305864 16307132 16305897 16307421 16306782 16412939 16306691 16304540 16305993 16306144 16306724 16307095 16307238 16307031 16306324 16306731 16307165 16307138 16305383 16307094 16307005 16306282 16307215 16306544 16307163 16306844 16306988 16305863 16306783 16306258 16307479 16304883 16306852 16307378 16307136 16306866 16307049 16306903 16305010 16306952 16307091 16304922 16307389 16294173 16306250 16307508 16306530 16305266 16305361 16306912 16307024 16305985 16307310 16306915 16305918 16408571 16424860 16428232 16395865 16419208 16422463 16396350 16405652 16411508 16405759 16410726 16431523 16382647 16410597 16422523 16439410 16373945 16411646 16411066 16410949 16410907 16403520 16423002 16407865 16432538 16393069 16409977 16393160 16402880 16396905 16405607 16374597 16411456 16410487 16393153 16410863 16395368 16423835 16409770 16410596 16374504 16390987 16410035 16410547 16405544 16404277 16422875 16395644 16393161 16438985 16393101 16406629 16408211 16424706 16391065 16395742 16374980 16409586 16420098 16374521 16396300 16408068 16393207 16409358 16405322 16409399 16405642 16408611 16405583…
FDA’s list runs to 181,453 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 181,453 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.