The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple…
Medical device recall Z-2682-2017. 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
- 7351 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.
7351 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
List number: 20679 Serial Number 15441019 15441020 15441037 15441044 15441082 15441093 15441118 15441226 15441229 15441230 15441240 15441241 15441244 15441246 15441247 15441249 15441253 15441256 15441258 15441260 15441265 15441266 15441270…
Every code shown here, 1,995 characters
List number: 20679 Serial Number 15441019 15441020 15441037 15441044 15441082 15441093 15441118 15441226 15441229 15441230 15441240 15441241 15441244 15441246 15441247 15441249 15441253 15441256 15441258 15441260 15441265 15441266 15441270 15441271 15441272 15441275 15441285 15441303 15441304 15441315 15441318 15441321 15441323 15441325 15441349 15441350 15441367 15441369 15441371 15441372 15441378 15441395 15441399 15441405 15441409 15441411 15441437 15441458 15441489 15441492 15441493 15441502 15441506 15441508 15441513 15441515 15441516 15441520 15441522 15441524 15441526 15441528 15441532 15441533 15441534 15441535 15441536 15441554 15441601 15441604 15441605 15441610 15441611 15441615 15441633 15441637 15441638 15441649 15441704 15441765 15441803 15441816 15441839 15441942 15441960 15441966 15442037 15442062 15442090 15442124 15442126 15442157 15442193 15442197 15442207 15442235 15442280 15442304 15442306 15442327 15442370 15442401 15442408 15442417 15442448 15442457 15442512 15442544 15442663 15442831 15442838 15442841 15442893 15442905 15442920 15442927 15442961 15442974 15442979 15442998 15443001 15443003 15443005 15443006 15443007 15443008 15443010 15443018 15443023 15443025 15443027 15443028 15443030 15443033 15443034 15443039 15443040 15443062 15443067 15443069 15443103 15443119 15443123 15443126 15443130 15443142 15443148 15443154 15443228 15443248 15443317 15443342 15443346 15443365 15443401 15443403 15443426 15443427 15443445 15443474 15443475 15443478 15443518 15443529 15443533 15443535 15443537 15443542 15443589 15443607 15443609 15443614 15443618 15443619 15443626 15443629 15443635 15443637 15443640 15443642 15443650 15443668 15443671 15443683 15443688 15443719 15443744 15443756 15443757 15443759 15443760 15443771 15443785 15443787 15443789 15443799 15443801 15443808 15443820 15443825 15443830 15443833 15443837 15443859 15443865 15443868 15443879 15443880 15443895 15443910 15443919 15443923 15443927 15443928 15443929 15443934 15443935 15443936…
FDA’s list runs to 66,193 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 66,193 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.