The Plum A+ Infusion Systems are a multipurpose family of devices that provides precise delivery of multiple…
Medical device recall Z-2680-2017. 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
- 7848 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.
7848 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
List number: 12618 Serial Number 14040001 14040002 14040004 14040005 14040006 14040008 14040009 14040010 14040011 14040012 14040014 14040015 14040016 14040017 14040018 14040019 14040020 14040021 14040022 14040023 14040024 14040025 14040026…
Every code shown here, 1,995 characters
List number: 12618 Serial Number 14040001 14040002 14040004 14040005 14040006 14040008 14040009 14040010 14040011 14040012 14040014 14040015 14040016 14040017 14040018 14040019 14040020 14040021 14040022 14040023 14040024 14040025 14040026 14040027 14040027 14040027 14040028 14040028 14040028 14040029 14040030 14040031 14040033 14040034 14040034 14040034 14040035 14040036 14040037 14040038 14040039 14040040 14040041 14040042 14040043 14040044 14040045 14040047 14040048 14040049 14040050 14040051 14040052 14040053 14040054 14040056 14040059 14040061 14040062 14040063 14040064 14040065 14040066 14040067 14040068 14040069 14040070 14040071 14040072 14040073 14040074 14040075 14040076 14040077 14040078 14040079 14040080 14040081 14040082 14040083 14040084 14040085 14040086 14040087 14040088 14040089 14040090 14040091 14040092 14040093 14040094 14040095 14040096 14040097 14040098 14040099 14040100 14040101 14040103 14040104 14040105 14040106 14040107 14040108 14040109 14040110 14040111 14040112 14040113 14040115 14040116 14040117 14040118 14040119 14040120 14040121 14040122 14040123 14040124 14040125 14040128 14040129 14040130 14040131 14040132 14040133 14040134 14040135 14040136 14040138 14040139 14040140 14040141 14040142 14040143 14040144 14040145 14040146 14040148 14040149 14040150 14040152 14040153 14040154 14040155 14040156 14040156 14040156 14040157 14040158 14040159 14040160 14040161 14040162 14040163 14040164 14040165 14040166 14040167 14040168 14040169 14040170 14040171 14040172 14040173 14040174 14040175 14040176 14040178 14040179 14040180 14040181 14040181 14040181 14040182 14040183 14040184 14040185 14040186 14040187 14040189 14040190 14040191 14040192 14040193 14040194 14040196 14040198 14040199 14040200 14040201 14040202 14040203 14040205 14040206 14040207 14040208 14040209 14040210 14040211 14040212 14040213 14040214 14040215 14040216 14040217 14040219 14040220 14040221 14040223 14040224 14040225 14040226 14040227 14040228 14040229 14040230 14040231…
FDA’s list runs to 70,666 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 70,666 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.