The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple…
Medical device recall Z-2681-2017. Published in FDA’s Enforcement Report on Jul 19, 2017.
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 19, 2017. 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
- 21703 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 possible interruption of therapy when an E321 error code occurs while using the infuser, which is caused by battery issues.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self contained, microprocessor based infusion devices. The pumps are available in single channel and in triple channel pumping mechanism types.
21703 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
List number: 20678 Serial Number 15541001 15541011 15541021 15541031 15541041 15541051 15541061 15541071 15541081 15541091 15541101 15541111 15541121 15541131 15541141 15541151 15541161 15541171 15541181 15541191 15541201 15541211 15541231…
Every code shown here, 1,995 characters
List number: 20678 Serial Number 15541001 15541011 15541021 15541031 15541041 15541051 15541061 15541071 15541081 15541091 15541101 15541111 15541121 15541131 15541141 15541151 15541161 15541171 15541181 15541191 15541201 15541211 15541231 15541241 15541261 15541271 15541281 15541291 15541301 15541311 15541321 15541331 15541341 15541351 15541361 15541371 15541381 15541391 15541401 15541411 15541421 15541431 15541441 15541451 15541461 15541471 15541481 15541491 15541501 15541511 15541521 15541531 15541541 15541551 15541561 15541571 15541581 15541591 15541601 15541611 15541621 15541631 15541641 15541651 15541661 15541671 15541681 15541691 15541701 15541711 15541721 15541731 15541741 15541751 15541761 15541771 15541781 15541791 15541801 15541811 15541821 15541831 15541841 15541851 15541861 15541871 15541881 15541891 15541901 15541911 15541921 15541931 15541941 15541951 15541961 15541971 15541981 15541991 15542001 15542011 15542021 15542031 15542041 15542051 15542061 15542071 15542081 15542091 15542101 15542111 15542121 15542131 15542141 15542151 15542161 15542171 15542181 15542191 15542201 15542211 15542221 15542231 15542241 15542251 15542261 15542271 15542281 15542291 15542301 15542311 15542321 15542331 15542341 15542351 15542361 15542371 15542381 15542391 15542401 15542411 15542431 15542441 15542451 15542461 15542471 15542481 15542491 15542501 15542511 15542521 15542531 15542541 15542551 15542561 15542571 15542581 15542591 15542601 15542611 15542621 15542631 15542641 15542651 15542661 15542671 15542681 15542691 15542701 15542711 15542721 15542731 15542741 15542751 15542761 15542771 15542781 15542791 15542801 15542811 15542821 15542831 15542841 15542851 15542861 15542871 15542881 15542891 15542911 15542921 15542931 15542941 15542951 15542961 15542971 15542981 15542991 15543001 15543011 15543021 15543031 15543041 15543051 15543061 15543081 15543101 15543111 15543121 15543131 15543141 15543151 15543161 15543181 15543191 15543211 15543221 15543231 15543241 15543261…
FDA’s list runs to 213,811 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.
Nationwide, Worldwide
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 Feb 1, 2013.
- FDA classified it on Jul 10, 2017.
- FDA’s Enforcement Report published it on Jul 19, 2017.
- FDA terminated it on May 31, 2018.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- ICU, of Lake Forest, IL.
- 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 213,811 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.