Ivenix Infusion System (IIS), Large Volume Pump LVP-0004
Medical device recall Z-0549-2024. Published in FDA’s Enforcement Report on Dec 27, 2023.
- 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 Dec 27, 2023. Copied from openFDA on Oct 20, 2026.
- Class I FDA’s most serious class (needs attention)
- Ongoing its status, in FDA’s file
- 5 states named in where it went
- 938 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?
The device may experience mechanical interference on the Fluid Valve pins, which will trigger a Pump Problem alarm. The issue may lead to delay or interruption of therapy. Depending on the therapy and duration of delay/interruption, the issue may lead to serious harm or death.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Ivenix Infusion System (IIS), Large Volume Pump LVP-0004
938 US, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI-DI 00811505030320 Serial numbers 2213800363 2213800343 2213800328 2213800222 2213800173 2212201120 2212201119 2212201118 2212201115 2212201113 2212201111 2212201100 2212201095 2212201093 2212201088 2212201076 2212201074 2212201061…
Every code shown here, 1,995 characters
UDI-DI 00811505030320 Serial numbers 2213800363 2213800343 2213800328 2213800222 2213800173 2212201120 2212201119 2212201118 2212201115 2212201113 2212201111 2212201100 2212201095 2212201093 2212201088 2212201076 2212201074 2212201061 2212201059 2212201046 2212201029 2212201024 2212201003 2212201002 2212200993 2212200990 2212200987 2212200986 2212200982 2212200978 2212200958 2212200952 2212200945 2212200938 2212200929 2212200914 2205900177 2205900176 2205900170 2205900167 2205900158 2205900152 2205900150 2205900143 2205900133 2205900132 2205900128 2205900126 2205900125 2205900113 2205900112 2205900110 2205900109 2205900108 2205900107 2205900106 2205900098 2205900096 2205900094 2205900091 2205900090 2205900074 2205900072 2205900071 2205900067 2205900062 2205900061 2201811620 2201811615 2201811614 2201811605 2118200011 2201811603 2201811600 2201811598 2201811597 2201811596 2201811594 2201811590 2201811585 2201811584 2201811582 2201811579 2201811577 2201811568 2201811567 2201811561 2201811560 2119300422 2201811554 2119300424 2201811550 2201811549 2201811548 2201811545 2201811542 2201811541 2119300431 2201811539 2201811533 2119300434 2119300435 2119300436 2119300437 2119300438 2201811532 2201811530 2201811529 2119300442 2201811527 2201811526 2201811524 2124300052 2201811520 2201811519 2201811517 2201811514 2201811510 2201811507 2201811503 2124300060 2201811499 2201811493 2201811488 2201811484 2201811482 2201811481 2201811479 2201811477 2201811476 2201811474 2201811471 2201811467 2201811460 2201811459 2201811457 2124300076 2201811454 2201811453 2201811451 2201811449 2201811445 2201811444 2201811443 2124300084 2201811439 2201811434 2201811433 2201811432 2124300089 2201811431 2201811430 2201811429 2201811428 2124300094 2201811419 2124300096 2201811416 2201811415 2201811414 2124300100 2201811412 2201811411 2201811409 2201811405 2201811404 2201811400 2201811399 2201811398 2124300109 2124300110 2201811397 2201811395 2201811391 2201811390 2201811388 2201811385 2201811384…
FDA’s list runs to 10,354 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 distribution to states of: CA, CO, NJ, UT, and WI.
The states and territories these words name
- California
- Colorado
- New Jersey
- Utah
- Wisconsin
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
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 Nov 29, 2023.
- FDA classified it on Dec 20, 2023.
- FDA’s Enforcement Report published it on Dec 27, 2023.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Fresenius Kabi USA, LLC, of North Andover, MA.
- 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 10,354 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.