Alaris PC unit
Medical device recall Z-1811-2015. Published in FDA’s Enforcement Report on Jun 24, 2015.
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 Jun 24, 2015. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 63 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 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?
An issue with the cancel functionality used during atypical infusion programming to cancel user inputted values. An infusion may start that is greater than or less than the hospital established limits for the specific medication.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Alaris PC unit model 8015, Infusion pump. software version 9.17 Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. The software is embedded in the Alaris PC unit.
63 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
2000863 2000879 2000946 12473445 12473494 12473519 12473530 12473531 12473535 12473629 12473840 12473846 12494992 12495525 12496140 12496473 12496474 12496493 12496497 12496514 12496528 12496529 12496551 12496552 12496554 12496568 12496570…
Every code shown here, 1,995 characters
2000863 2000879 2000946 12473445 12473494 12473519 12473530 12473531 12473535 12473629 12473840 12473846 12494992 12495525 12496140 12496473 12496474 12496493 12496497 12496514 12496528 12496529 12496551 12496552 12496554 12496568 12496570 12496571 12496572 12496591 12496594 12496595 12505909 12519370 12540760 12577165 12578322 12578596 12578604 12578636 12578645 12578662 12578687 12578750 12578762 12578857 12578899 12579095 12579194 12579499 12579566 12579643 12579689 12581148 12584449 12625758 12625765 12625901 12625916 12625930 12625933 12628604 12630285 12630778 12634157 12634382 12634783 12635363 12635391 12635539 12635928 12636509 12636901 12636967 12636979 12636980 12636984 12636985 12637133 12637353 12637658 12637799 12637853 12637881 12637907 12639373 12639381 12639382 12639406 12639410 12639414 12639495 12639536 12639552 12639555 12639558 12639583 12639590 12639617 12639636 12639637 12639646 12639647 12639650 12639683 12639688 12639699 12639701 12639709 12639710 12639712 12639793 12639795 12639797 12639828 12639839 12639840 12639848 12639849 12639862 12639865 12639881 12639905 12639908 12639940 12639958 12639971 12639990 12640010 12640014 12640059 12640060 12640062 12640063 12640064 12640107 12640115 12640116 12640142 12640143 12640145 12640148 12640169 12640171 12640177 12640201 12640204 12640205 12640236 12640239 12640240 12640241 12640267 12640269 12640273 12640275 12640295 12640296 12640300 12640302 12640317 12640319 12640321 12640332 12640333 12640350 12640352 12640353 12640365 12640366 12640375 12640399 12640400 12640419 12640439 12640440 12640461 12640466 12640470 12640521 12640530 12640533 12640535 12640536 12640546 12640547 12640548 12640567 12640568 12640583 12640584 12640587 12640588 12640590 12640603 12640626 12640627 12640628 12640658 12640671 12640672 12640677 12640694 12640697 12640709 12640737 12640774 12640775 12640777 12640778 12640801 12640809 12640822 12640849 12640856 12640859 12640866 12640867 12640870 12640872 12640875 12640876…
FDA’s list runs to 108,597 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.
US Nationwide Distribution
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.
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 May 13, 2015.
- FDA classified it on Jun 16, 2015.
- FDA’s Enforcement Report published it on Jun 24, 2015.
- FDA terminated it on May 20, 2016.
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 108,597 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.