Alaris PC units
Medical device recall Z-1311-2015. Published in FDA’s Enforcement Report on Apr 1, 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 Apr 1, 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
- 56,015 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?
CareFusion is recalling the Alaris PC unit because of an error code. The error code may occur upon power on during the “Power-On Self Test” due to a keypad issue.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Alaris PC units, Model No. 8015. Infusion pump.
56,015 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial No. 13874997 13875013 13875014 13875053 13875060 13875186 13875188 13875192 13875198 13875200 13875202 13875203 13875251 13875252 13875301 13875407 13875437 13875556 13875674 13875985 13876089 13876108 13876859 13877010 13877031…
Every code shown here, 2,000 characters
Serial No. 13874997 13875013 13875014 13875053 13875060 13875186 13875188 13875192 13875198 13875200 13875202 13875203 13875251 13875252 13875301 13875407 13875437 13875556 13875674 13875985 13876089 13876108 13876859 13877010 13877031 13877035 13877044 13877050 13877077 13877093 13877119 13877201 13877238 13877274 13877279 13877364 13877378 13877381 13877383 13877409 13877425 13877443 13877514 13877515 13877533 13877763 13877783 13877807 13877818 13877832 13877834 13877878 13877880 13877891 13877901 13877939 13877943 13877978 13877998 13877999 13878005 13878009 13878021 13878035 13878037 13878052 13878056 13878086 13878088 13878092 13878093 13878095 13878357 13878407 13878415 13878423 13878440 13878446 13878462 13878510 13878514 13878558 13878561 13878594 13878598 13878601 13878664 13879514 13879551 13879552 13879616 13879620 13879646 13879656 13879657 13879659 13879660 13879661 13879702 13879703 13879705 13879714 13879744 13879747 13879767 13879769 13879781 13879846 13879870 13879873 13879877 13879891 13879893 13879932 13879978 13880010 13880011 13880030 13880060 13880130 13880156 13880159 13880171 13880172 13880203 13880204 13880205 13880224 13880230 13880258 13880275 13880285 13880394 13880397 13880403 13880465 13880466 13880471 13880473 13880474 13880512 13880514 13880515 13880516 13880517 13880576 13880579 13880611 13880612 13880614 13880625 13880655 13880660 13880662 13880678 13880679 13880685 13880762 13880801 13880823 13880916 13880917 13880918 13880922 13880924 13880935 13881090 13881099 13881189 13881249 13881318 13881319 13881320 13881363 13881364 13881365 13881366 13882390 13753727 13758216 13758453 13759249 13759574 13759591 13759609 13759614 13759930 13759939 13759950 13760319 13760340 13760342 13760373 13760386 13760402 13760427 13760461 13760469 13760472 13760473 13760478 13760487 13760530 13760555 13760742 13760746 13760779 13760801 13760804 13760814 13760817 13760833 13760835 13760836 13760837 13760841 13760842 13760846 13760848 13760850 13760851…
FDA’s list runs to 536,445 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 - USA (nationwide), Canada, European Union, Singapore and Australia.
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 Mar 12, 2015.
- FDA classified it on Mar 23, 2015.
- FDA’s Enforcement Report published it on Apr 1, 2015.
- FDA terminated it on Sep 25, 2017.
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 536,445 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.