The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple…
Medical device recall Z-2676-2017. 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
- 10609 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.
10609 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
List number 11971; Serial Numbers 13120009 13120017 13120018 13120019 13120026 13120028 13120037 13120041 13120042 13120044 13120057 13120058 13120068 13120071 13120074 13120075 13120082 13120096 13120103 13120104 13120107 13120108…
Every code shown here, 1,996 characters
List number 11971; Serial Numbers 13120009 13120017 13120018 13120019 13120026 13120028 13120037 13120041 13120042 13120044 13120057 13120058 13120068 13120071 13120074 13120075 13120082 13120096 13120103 13120104 13120107 13120108 13120109 13120115 13120128 13120138 13120143 13120153 13120160 13120164 13120168 13120171 13120174 13120177 13120186 13120187 13120200 13120205 13120220 13120222 13120223 13120226 13120231 13120235 13120237 13120238 13120239 13120247 13120248 13120249 13120251 13120253 13120262 13120270 13120271 13120277 13120279 13120285 13120293 13120294 13120295 13120297 13120303 13120310 13120311 13120314 13120320 13120329 13120343 13120344 13120346 13120353 13120354 13120357 13120359 13120365 13120366 13120367 13120370 13120385 13120390 13120391 13120394 13120399 13120401 13120405 13120419 13120422 13120424 13120440 13120441 13120452 13120460 13120462 13120467 13120472 13120483 13120487 13120496 13120502 13120508 13120537 13120543 13120549 13120557 13120558 13120563 13120565 13120567 13120568 13120576 13120580 13120582 13120585 13120586 13120589 13120591 13120593 13120595 13120596 13120598 13120599 13120606 13120607 13120611 13120612 13120613 13120615 13120626 13120627 13120629 13120630 13120634 13120639 13120644 13120659 13120661 13120665 13120666 13120676 13120677 13120683 13120684 13120692 13120698 13120705 13120707 13120710 13120712 13120721 13120723 13120725 13120726 13120737 13120743 13120751 13120759 13120769 13120772 13120780 13120784 13120788 13120802 13120808 13120823 13120826 13120827 13120829 13120835 13120836 13120837 13120842 13120846 13120850 13120855 13120857 13120858 13120863 13120865 13120867 13120868 13120871 13120872 13120877 13120881 13120885 13120887 13120891 13120894 13120896 13120906 13120909 13120919 13120922 13120924 13120937 13120940 13120941 13120942 13120943 13120946 13120947 13120950 13120956 13120967 13120970 13120973 13120978 13120991 13120997 13121020 13121035 13121040 13121044 13121045 13121050 13121052 13121059…
FDA’s list runs to 102,869 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 102,869 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.