The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple…
Medical device recall Z-2679-2017. 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
- 184399 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.
184399 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
List number: 12391 Serial Number 13840001 13840002 13840003 13840004 13840005 13840006 13840007 13840008 13840009 13840010 13840011 13840012 13840013 13840014 13840015 13840016 13840017 13840018 13840019 13840020 13840021 13840022 13840023…
Every code shown here, 1,995 characters
List number: 12391 Serial Number 13840001 13840002 13840003 13840004 13840005 13840006 13840007 13840008 13840009 13840010 13840011 13840012 13840013 13840014 13840015 13840016 13840017 13840018 13840019 13840020 13840021 13840022 13840023 13840024 13840025 13840026 13840027 13840028 13840029 13840030 13840031 13840032 13840033 13840034 13840035 13840036 13840037 13840038 13840039 13840040 13840041 13840042 13840043 13840044 13840045 13840046 13840047 13840048 13840049 13840050 13840051 13840052 13840053 13840054 13840055 13840056 13840057 13840058 13840059 13840060 13840061 13840062 13840063 13840064 13840065 13840066 13840067 13840068 13840069 13840070 13840071 13840072 13840073 13840074 13840075 13840076 13840077 13840078 13840079 13840080 13840081 13840082 13840083 13840084 13840085 13840086 13840087 13840088 13840089 13840090 13840091 13840092 13840093 13840094 13840095 13840096 13840097 13840098 13840099 13840100 13840101 13840102 13840103 13840104 13840105 13840106 13840107 13840108 13840109 13840110 13840111 13840112 13840113 13840114 13840115 13840116 13840117 13840118 13840119 13840120 13840122 13840123 13840124 13840125 13840126 13840127 13840128 13840129 13840130 13840131 13840132 13840133 13840134 13840135 13840136 13840137 13840138 13840139 13840140 13840141 13840142 13840143 13840144 13840145 13840146 13840147 13840148 13840149 13840150 13840151 13840152 13840153 13840154 13840155 13840156 13840157 13840158 13840159 13840160 13840161 13840162 13840163 13840164 13840165 13840166 13840167 13840168 13840169 13840170 13840171 13840172 13840173 13840174 13840175 13840176 13840177 13840178 13840179 13840180 13840181 13840182 13840183 13840184 13840185 13840187 13840188 13840189 13840190 13840191 13840192 13840193 13840194 13840195 13840196 13840197 13840198 13840199 13840200 13840201 13840202 13840203 13840204 13840205 13840206 13840207 13840208 13840209 13840210 13840211 13840212 13840213 13840214 13840215 13840216 13840217 13840218 13840219 13840220…
FDA’s list runs to 1,840,821 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 1,840,821 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.