Alaris PC unit
Medical device recall Z-1835-2013. Published in FDA’s Enforcement Report on Aug 14, 2013.
- 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 14, 2013. 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
- 26,564 total units (26,220 units for US) 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?
CareFusion is recalling the Alaris PC units model 8015 (PC unit), version 9.12, because it is operating at an incorrect voltage and it could potentially experience a loss of communication between the PC Unit main Processor and Keyboard Processor.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Alaris PC unit, model 8015, with version 9.12-Keyboard Processor and logic board assembly part number TC10006584. The Alaris PC Unit is the main user interface unit and power supply of the Alaris System, a modular system to be used with Alaris System modules intended for use in todays growing professional healthcare environment for facilities that utilize infusion and/or monitoring devices.
26,564 total units (26,220 units for US), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
1005435 10038007 1300550 3894703 1003149 19995706 3895887 19995118 1022500 1257000 1010235 3894799 1264612 1029800 10032389 3894714 3894796 1039450 19995610 3894886 1058150 1129100 1003197 1065900 3894701 10063252 1610200 1074200 3894708…
Every code shown here, 1,852 characters
1005435 10038007 1300550 3894703 1003149 19995706 3895887 19995118 1022500 1257000 1010235 3894799 1264612 1029800 10032389 3894714 3894796 1039450 19995610 3894886 1058150 1129100 1003197 1065900 3894701 10063252 1610200 1074200 3894708 10142044 1296030 1020387 3894811 1083900 10115320 1101500 1102400 1101601 10038966 19995620 3894841 1123000 1135600 1137240 1353400 3894860 1547000 1008565 1186900 6169100 10008460 3894844 1155500 3894711 10032361 10166465 3894702 10046069 10037661 10037647 3894834 3894836 10034261 1297400 1302600 1053000 1317801 3894817 3894797 10163092 10053161 1012161 3895854 10046578 1369040 1005333 1375900 10001956 3894734 3894789 3894833 10047157 1403100 1408700 10010196 3894892 3894765 1433251 1009496 1446000 1438800 1865900 1911872 10010570 19996156 10033408 1589480 1453703 1466600 1453702 6273300 10011620 1470203 1477201 1765300 1025650 10037131 19995384 1915200 1470204 1315403 10044246 1470001 1470202 19995746 6129700 1726300 1505700 10063253 10037742 1131700 10037723 4513601 1520101 1001799 10010451 4538200 10122836 1001783 1553400 1220200 3894705 1907800 1000456 6572500 19996529 10038213 3894830 1843701 10165568 1579040 10035744 10060127 3894819 3895895 1027700 1623400 1012793 10149088 3894849 1492500 1719500 10033426 1677100 1697501 1703300 6237701 1716400 1018653 10011474 1725100 1724300 1252400 6598300 1738700 6606300 10002540 19995700 10047163 1793108 3894718 1797801 10038591 1016746 1079000 1442503 19995670 10032641 1043750 1015768 1812600 1813200 1833900 1842600 1846801 1838401 1027503 1846000 10046982 10049664 10049674 10042072 10158492 10040131 1845700 3872400 3894825 3895883 3894801 3880600 3894722 3894716 3894723 3895875 3888400 6840950 10036536 3894870 1908600 1037000 1012361 19995045 10165422 10165005 10005354 10011455 1933600 3894735 1944700 980 500 10167738 111 10161003 10001154
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 countries of: Australia, Canada and Europe.
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 Jun 17, 2013.
- FDA classified it on Aug 2, 2013.
- FDA’s Enforcement Report published it on Aug 14, 2013.
- FDA terminated it on May 20, 2014.
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.”
- 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.