The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple…
Medical device recall Z-2683-2017. 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
- 363892 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.
363892 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
List number: 20792 Serial Number 16061001 16061002 16061003 16061004 16061005 16061006 16061007 16061008 16061009 16061010 16061011 16061012 16061013 16061014 16061015 16061016 16061017 16061018 16061019 16061020 16061021 16061022 16061023…
Every code shown here, 1,995 characters
List number: 20792 Serial Number 16061001 16061002 16061003 16061004 16061005 16061006 16061007 16061008 16061009 16061010 16061011 16061012 16061013 16061014 16061015 16061016 16061017 16061018 16061019 16061020 16061021 16061022 16061023 16061025 16061026 16061027 16061028 16061029 16061030 16061031 16061032 16061033 16061034 16061035 16061036 16061037 16061038 16061039 16061040 16061041 16061042 16061043 16061044 16061045 16061046 16061047 16061048 16061049 16061050 16061051 16061052 16061053 16061054 16061055 16061056 16061057 16061058 16061059 16061060 16061061 16061062 16061063 16061064 16061065 16061066 16061067 16061068 16061069 16061070 16061071 16061072 16061073 16061074 16061075 16061076 16061077 16061078 16061079 16061080 16061081 16061082 16061083 16061084 16061085 16061086 16061087 16061088 16061089 16061090 16061091 16061092 16061093 16061094 16061095 16061096 16061097 16061098 16061099 16061100 16061101 16061102 16061103 16061104 16061105 16061106 16061107 16061108 16061109 16061110 16061111 16061112 16061113 16061114 16061115 16061116 16061117 16061118 16061119 16061120 16061121 16061122 16061123 16061124 16061125 16061126 16061127 16061128 16061129 16061130 16061131 16061132 16061133 16061134 16061135 16061136 16061137 16061138 16061139 16061140 16061141 16061142 16061143 16061144 16061145 16061146 16061147 16061148 16061149 16061150 16061151 16061152 16061153 16061154 16061155 16061156 16061157 16061158 16061159 16061160 16061161 16061162 16061163 16061164 16061165 16061166 16061167 16061168 16061169 16061170 16061171 16061172 16061173 16061174 16061175 16061176 16061177 16061178 16061179 16061180 16061181 16061182 16061183 16061184 16061185 16061186 16061187 16061188 16061189 16061190 16061191 16061192 16061193 16061194 16061195 16061196 16061197 16061198 16061199 16061200 16061201 16061202 16061203 16061204 16061205 16061206 16061207 16061208 16061209 16061210 16061211 16061212 16061213 16061214 16061215 16061216 16061217 16061218 16061219…
FDA’s list runs to 1,311,985 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 1,311,985 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.