Ivenix Infusion System (IIS)
Medical device recall Z-1381-2022. Published in FDA’s Enforcement Report on Jul 20, 2022.
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 20, 2022. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 2 states named
- 1335 devices 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?
Downstream occlusion alarm is sometimes immediately followed by a pump problem alarm.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Ivenix Infusion System (IIS)
1335 devices, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI-DI: LVP-SW-0004 Software version 5.0 System serial numbers: 2118200011 2119300411 2119300414 2119300415 2119300417 2119300418 2119300421 2119300422 2119300423 2119300424 2119300425 2119300426 2119300427 2119300428 2119300429 2119300430…
Every code shown here, 2,000 characters
UDI-DI: LVP-SW-0004 Software version 5.0 System serial numbers: 2118200011 2119300411 2119300414 2119300415 2119300417 2119300418 2119300421 2119300422 2119300423 2119300424 2119300425 2119300426 2119300427 2119300428 2119300429 2119300430 2119300431 2119300432 2119300434 2119300435 2119300436 2119300437 2119300438 2119300439 2119300440 2119300441 2119300442 2124300050 2124300051 2124300052 2124300055 2124300058 2124300062 2124300067 2124300068 2124300070 2124300073 2124300074 2124300076 2124300078 2124300079 2124300081 2124300082 2124300084 2124300086 2124300087 2124300088 2124300089 2124300090 2124300092 2124300094 2124300095 2124300096 2124300101 2124300102 2124300105 2124300123 2124300124 2124300127 2124300133 2124300137 2124300141 2124300130 2124300114 2124300140 2124300115 2124300129 2124300100 2124300109 2124300110 2118200008 2119300412 2119300416 2124300049 2124300053 2124300054 2124300056 2124300059 2124300060 2124300061 2124300064 2124300065 2124300066 2124300069 2124300071 2124300072 2124300075 2124300077 2124300080 2124300083 2124300085 2124300091 2124300093 2124300097 2124300104 2124300106 2124300107 2124300108 2124300112 2124300116 2124300118 2124300119 2124300120 2124300121 2124300122 2124300125 2124300128 2124300131 2124300132 2124300134 2124300135 2124300138 2124300139 2124300142 2124300143 2124300144 2124300145 2124300146 2124300147 2124300148 2124300150 2124300152 2124300153 2124300154 2124300155 2124300156 2124300157 2124300159 2124300160 2124300161 2124300162 2124300163 2124300164 2124300166 2124300167 2124300168 2124300169 2124300170 2124300171 2124300172 2124300173 2124300174 2124300175 2124300176 2124300177 2124300178 2124300179 2124300180 2124300181 2124300183 2124300184 2124300185 2124300186 2124300187 2124300188 2125900425 2125900426 2125900427 2125900428 2125900429 2125900431 2125900432 2125900434 2125900435 2125900436 2125900437 2125900438 2125900439 2125900440 2125900441 2125900442 2125900443 2125900444 2125900445 2125900447 2125900448…
FDA’s list runs to 14,748 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 Nationwide distribution in the states of NJ and WI.
The states and territories these words name
- New Jersey
- Wisconsin
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 Apr 22, 2022.
- FDA classified it on Jul 13, 2022.
- FDA’s Enforcement Report published it on Jul 20, 2022.
- FDA terminated it on May 20, 2024.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Ivenix, Inc., 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 14,748 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.