Aftermarket Alaris Infusion Pump Module
Medical device recall Z-1375-2021. Published in FDA’s Enforcement Report on Apr 28, 2021.
- 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 Apr 28, 2021. Copied from openFDA on Oct 20, 2026.
- Class I FDA’s most serious class (needs attention)
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 2452 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?
Aftermarket front bezel components were installed during service/repair, not by the original manufacturer, within infusion pump modules. Over time, the posts on the front bezel component may crack or separate. Separation of one or more bezel posts could lead to free flow, over infusion, under infusion, or interruption of infusion.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Aftermarket Alaris Infusion Pump Module Model 8100 Front Bezel, installed by Pacific Medical Group (DBA Avante Health Solutions)
2452, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers of devices serviced/purchased 07/10/2020-02/18/2021: 4105026 4122780 9925856 9961244 12333241 12333419 12333802 12334211 12334212 12334213 12334214 12334319 12334403 12334424 12334452 12334652 12334713 12334833 12334896…
Every code shown here, 1,999 characters
Serial Numbers of devices serviced/purchased 07/10/2020-02/18/2021: 4105026 4122780 9925856 9961244 12333241 12333419 12333802 12334211 12334212 12334213 12334214 12334319 12334403 12334424 12334452 12334652 12334713 12334833 12334896 12334950 12334951 12334957 12335116 12335128 12335147 12335159 12335163 12335212 12335232 12335260 12335304 12335380 12335427 12335481 12335513 12335522 12335570 12335596 12335606 12335625 12335642 12335673 12335722 12335754 12335790 12335792 12335883 12335904 12335921 12335926 12335967 12335970 12336005 12336011 12336156 12336165 12336273 12336275 12336279 12336280 12336293 12336305 12336395 12336402 12336403 12336430 12336435 12336461 12336630 12336668 12336694 12336971 12337823 12421700 12517224 12524554 12524783 12544522 12568207 12570110 12570217 12571055 12580490 12586058 12586274 12586333 12587144 12588342 12590617 12590762 12591783 12591900 12592059 12592353 12592442 12592545 12592622 12592624 12592771 12592840 12592879 12592944 12592968 12592979 12593139 12593231 12594623 12595031 12595247 12595693 12595881 12595943 12595992 12596068 12596243 12596303 12597046 12597178 12597462 12597465 12597556 12597699 12598072 12598088 12598112 12598125 12640247 12640292 12641907 12650197 12655100 12740634 12743978 12744142 12755303 12767321 12779073 12793502 12793519 12793565 12793610 12815356 12822657 12822783 12823029 12823031 12823099 12823177 12827621 12828337 12875779 12876033 12877579 12897320 12961435 12993617 13022654 13057056 13066426 13066442 13066455 13066498 13066510 13066511 13066525 13066560 13066570 13066618 13066637 13066674 13066680 13066683 13066696 13066713 13066715 13066756 13066798 13066808 13066858 13066877 13066887 13066899 13066965 13067206 13067213 13067257 13067270 13067271 13067282 13067283 13067340 13067343 13067423 13067428 13067451 13067453 13067456 13067482 13067484 13067510 13067530 13067559 13067568 13067569 13067570 13067571 13067649 13067669 13067715 13067747 13067751 13067774 13067796 13067797 13067808…
FDA’s list runs to 22,112 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.
Distribution US nationwide.
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?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, 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 24, 2021.
- FDA classified it on Apr 19, 2021.
- FDA’s Enforcement Report published it on Apr 28, 2021.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Pacific Medical Group Inc., of San Clemente, 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 22,112 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.