Alaris Syringe Pump
Medical device recall Z-2362-2015. Published in FDA’s Enforcement Report on Aug 26, 2015.
- FDA Class I
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 Aug 26, 2015. Copied from openFDA on Oct 20, 2026.
- Class I FDA’s most serious class (needs attention)
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 68,460 units 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 I, the most serious of FDA’s three classes.
“Dangerous or defective products that predictably could cause serious health problems or death. Examples include: food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.”
openFDA, in plain words, its enforcement report fields.
“Class I is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”
FDA’s rule, 21 CFR 7.3(m)(1), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Channel Error code is displayed on the PC unit with an audio and visual alarm, and on the syringe module. After the error is cleared on the PCU, the syringe pump is unresponsive to key presses until the next power cycle, or the module is detached and reattached.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
68,460 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
4051531 4051532 4051533 4051534 4051535 4051684 4051685 4051686 4051687 4051688 4051689 4051690 4051691 4052487 4052488 4052489 4052490 4052492 4052493 4052495 4052497 4052499 4052500 4052501 4052502 4052503 4052504 4052505 4052507 4052509…
Every code shown here, 2,000 characters
4051531 4051532 4051533 4051534 4051535 4051684 4051685 4051686 4051687 4051688 4051689 4051690 4051691 4052487 4052488 4052489 4052490 4052492 4052493 4052495 4052497 4052499 4052500 4052501 4052502 4052503 4052504 4052505 4052507 4052509 4052510 4053437 4053547 4055907 4059581 4052494 4052496 4052508 4052511 4052491 4052498 4048982 4048983 4048985 4048986 4048987 4048988 4048990 4048991 4048992 4048993 4048994 4048995 4048996 4048997 4048999 4049000 4049002 4049231 4049232 4049233 4049234 4049236 4049237 4049238 4049239 4049241 4049242 4049243 4049244 4049245 4049246 4049248 4049250 4049251 4049252 4049253 4049255 4049256 4049257 4049989 4049990 4049991 4049993 4049994 4049996 4049997 4049998 4050000 4050001 4050002 4050003 4050004 4050005 4050006 4050008 4050010 4050011 4050012 4050013 4050449 4050450 4050451 4050452 4050453 4050454 4050456 4050457 4050458 4050459 4050460 4050461 4050462 4050463 4050465 4050466 4050467 4050469 4050470 4050471 4050472 4050473 4050702 4050703 4050704 4050705 4050706 4050707 4050708 4050710 4050711 4050713 4050715 4050716 4050717 4050718 4050719 4050720 4050721 4050722 4050723 4050725 4050726 4051145 4051146 4051147 4051148 4051149 4051424 4051425 4051426 4051427 4051428 4051429 4051430 4051431 4051432 4051433 4051508 4051509 4051510 4051511 4051512 4051513 4051514 4051515 4051516 4051517 4066478 4066482 4066484 4066487 4066489 4066490 4066497 4066498 4066499 4066504 4066505 4066506 4066508 4066510 4066519 4066520 4067370 4067373 4067375 4067376 4067377 4067378 4067380 4067383 4067384 4067386 4067388 4067389 4067390 4067393 4067394 4067396 4067397 4067398 4067399 4067400 4067401 4067403 4067404 4067405 4067406 4067408 4067410 4067411 4067413 4067414 4067417 4067418 4067419 4068073 4068074 4068077 4068079 4068080 4068168 4068170 4068171 4068786 4068787 4068788 4068789 4068790 4068791 4068792 4068794 4068797 4068798 4068799 4068800 4068801 4068803 4068804 4068805 4068806 4069206 4069566 4069567 4069568 4069569 4069584 4069585 4069586…
FDA’s list runs to 660,532 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 Distribution-US (nationwide) and the countries of Australia, New Zealand, South Africa, Canada, Middle East, Malaysia, and Taiwan.
These words name no state.
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?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, 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 Jul 21, 2015.
- FDA classified it on Aug 14, 2015.
- FDA’s Enforcement Report published it on Aug 26, 2015.
- FDA terminated it on Dec 14, 2018.
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 660,532 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
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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.