Alaris System PC Unit
Medical device recall Z-2064-2016. Published in FDA’s Enforcement Report on Jul 6, 2016.
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 Jul 6, 2016. 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
- 69,693 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?
A patient weight can be populated incorrectly under certain conditions when using the RESTORE feature to restore infusions running on the Alaris LVP module model 8100 and the Alaris Syringe module model 8110.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Alaris System PC Unit Model 8015 with software versions 9.17 and 9.19; Central programming, monitoring and power supply component for the Alaris System.
69,693 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial no. 14566816 14566942 14566976 14567039 14567041 14567050 14567060 14567079 14567084 14567085 14567126 14567131 14567132 14567144 14412839 14509419 14509442 14509601 14510079 14510087 14517114 14517126 14517135 14517137 14517139…
Every code shown here, 2,000 characters
Serial no. 14566816 14566942 14566976 14567039 14567041 14567050 14567060 14567079 14567084 14567085 14567126 14567131 14567132 14567144 14412839 14509419 14509442 14509601 14510079 14510087 14517114 14517126 14517135 14517137 14517139 14517179 14517183 14517186 14517193 14517202 14517205 14517208 14517214 14517218 14517220 14517246 14517250 14517253 14517254 14517256 14517257 14517259 14517260 14517282 14517286 14517287 14517296 14517297 14517301 14517303 14517305 14517309 14517310 14517312 14517314 14517315 14517316 14517318 14517319 14517323 14517324 14517326 14517327 14517336 14517337 14517339 14517341 14517345 14517346 14517351 14517356 14517359 14517360 14517362 14517363 14517364 14517369 14517372 14517373 14517378 14517381 14517383 14517388 14517389 14517391 14517393 14517396 14517400 14517401 14517402 14517403 14517409 14517415 14517417 14517418 14517421 14517424 14517428 14517430 14517431 14517433 14517437 14517438 14517440 14517441 14517443 14517446 14517448 14517449 14517450 14517451 14517452 14517453 14517456 14517458 14517460 14517461 14517464 14517472 14517478 14517479 14517481 14517483 14517484 14517489 14517490 14517491 14517493 14517494 14517501 14517507 14517508 14517509 14517510 14517511 14517513 14517516 14517518 14517519 14517520 14517526 14517527 14517529 14517531 14517536 14517539 14517543 14517544 14517549 14517561 14517564 14517565 14517566 14517572 14517587 14517595 14517602 14517604 14517610 14517611 14517612 14517614 14517615 14517621 14517622 14517629 14489940 14489967 14489979 14489990 14489994 14490000 14490001 14490006 14490007 14490009 14490010 14490020 14490025 14490027 14490033 14490036 14490048 14490084 14490088 14490107 14494296 14495152 14495259 14496092 14496173 14496184 14496234 14496237 14496259 14496265 14496273 14496325 14496364 14497035 14497039 14497047 14497048 14497051 14497057 14497059 14497062 14497066 14497067 14497068 14497069 14497070 14497077 14497080 14497118 14497192 14497207 14497209 14497211 14497217 14497219…
FDA’s list runs to 693,708 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.
Distributed US (nationwide) and in Canada.
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 12, 2016.
- FDA classified it on Jun 28, 2016.
- FDA’s Enforcement Report published it on Jul 6, 2016.
- FDA terminated it on Dec 24, 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 693,708 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.