The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple…
Medical device recall Z-2675-2017. 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
- 180 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.
180 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
List number: 11005; Serial Numbers: 16792201 16792202 16792205 16792206 16792208 16792209 16792210 16792211 16792213 16792216 16792217 16792219 16792220 16792222 16792223 16792224 16792225 16792226 16792227 16792228 16792230 16792232…
Every code shown here, 1,655 characters
List number: 11005; Serial Numbers: 16792201 16792202 16792205 16792206 16792208 16792209 16792210 16792211 16792213 16792216 16792217 16792219 16792220 16792222 16792223 16792224 16792225 16792226 16792227 16792228 16792230 16792232 16792233 16792234 16792235 16792236 16792238 16792239 16792240 16792241 16792242 16792244 16792245 16792246 16792248 16792249 16792250 16792251 16792252 16792253 16792254 16792255 16792256 16792257 16792258 16792259 16792260 16792261 16792263 16792264 16792265 16792266 16792268 16792269 16792271 16792272 16792273 18807402 18807405 18807406 18807407 18807408 18807409 18807410 18807413 18807414 18807417 18807418 18807420 18807421 18807423 18807427 18807428 18807429 18807430 18807431 18807432 18807433 18807434 18807439 18807443 18807444 18807446 18807449 18807452 18807453 18807455 18807456 18807459 18807463 18807466 18807472 18807474 18807478 18807484 18807485 18807486 18807490 18807491 18807494 18807496 18807499 18807500 18807501 18807506 18807509 18807510 18807511 18807513 18807514 18807518 18807523 18807524 18807529 18807535 18807536 18807539 18807540 18807541 18807542 18807543 18807545 18807546 18807556 18807557 18807568 18807574 18807575 18807576 18807578 18807581 18807584 18807585 18807586 18807588 18807589 18807590 18807591 18807592 18807596 18807597 18807598 18807599 18807600 18807601 18807602 18807604 18807605 18807607 18807608 18807609 18807610 18807611 18807612 18807613 18807614 18807617 18807618 18807619 18807620 18807623 18807625 18807626 18807627 18807628 18807630 18807631 18807632 18807633 18807634 18807636 18807637 18807639 18807640 18807695 18807696 18807697 18807698 18807699 18807700
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.”
- 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.