The Plum A+ Infusion System is designed to meet the fluid delivery requirements of today’s evolving…
Medical device recall Z-1075-2015. Published in FDA’s Enforcement Report on Mar 4, 2015.
- FDA Class I
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 Mar 4, 2015. Copied from openFDA on Oct 20, 2026.
- Class I FDA’s most serious class (needs attention)
- Terminated its status, in FDA’s file
- 50 states named in where it went
- 190 infusion pumps 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 I, the most serious of FDA’s three classes.
“Dangerous or defective products that predictably could cause serious health problems or death. Examples include: food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.”
openFDA, in plain words, its enforcement report fields.
“Class I is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”
FDA’s rule, 21 CFR 7.3(m)(1), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
One lot of alarm assemblies used in Plum A+ and Plum A+3 infusion pumps may fail to sound at all volume levels.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
The Plum A+ Infusion System is designed to meet the fluid delivery requirements of today’s evolving healthcare environments. It is a cassette based multi-function infusion system. The Plum A+ allows two lines in and one line out. The pump can be used for standard, piggyback, or concurrent delivery. Therapy modes include: Standard Infusions, Multistep Programming, Loading Dose, and Dose Calculation. The Plum A+ is designed to deliver parenteral, enteral, or epidural infusions over a broad range of infusion rates from multiple fluid container types. Each system includes a pumping module and an assortment of disposable IV sets, optional accessories, and an operator’s manual.
190 infusion pumps, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
1) List Number:12618: Serial Numbers: 14040926 , 14041563 , 14041565 , 14041611 , 14041627 , 14041901 , 14041912 , 14041921 , 14041953 , 14041960 , 14041964 , 14041973 , 14040654 , 14041065 , 14041554 , 14041604 , 14041606 , 14041621 ,…
Every code shown here, 1,996 characters
1) List Number:12618: Serial Numbers: 14040926 , 14041563 , 14041565 , 14041611 , 14041627 , 14041901 , 14041912 , 14041921 , 14041953 , 14041960 , 14041964 , 14041973 , 14040654 , 14041065 , 14041554 , 14041604 , 14041606 , 14041621 , 14041902 , 14042270 , 14042280 , 14042475 , 14042477 , 14042495 , 14042514 , 14042524 , 14044012 , 14044024 , 14040142 , 14041107 , 14041800 , 14041989 , 14042077 , 14042462 , 14042490 , 14042499 , 14042502 , 14042820 , 14043029 , 14043312 , 14043750 , 14044015 , 14044018 , 14044025 , 14044028 , 14044055 , 14044448 , 14044459 , 14044467 , 14044469 , 14044472 , 14044481 , 14044497 , 14044507 , 14044510 , 14044689 , 14045142 , 14045145 , 14045161 , 14045175 , 14045181 , 14045520 , 14045758 , 14045789 , 14045995 , 14046010 , 14047080 , 14047113 , 14047181 , 14047217 , 14040140 , 14040196 , 14040459 , 14040626 , 14040628 , 14040744 , 14040976 , 14041070 , 14041095 , 14041248 , 14041270 , 14041349 , 14041616 , 14041785 , 14041869 , 14042152 , 14042267 , 14042637 , 14042784 , 14043035 , 14043385 , 14044035 , 14044449 , 14044452 , 14044457 , 14044461 , 14044468 , 14044490 , 14044495 , 14044496 , 14044498 , 14044500 , 14044502 , 14044503 , 14044506 , 14044514 , 14044518 , 14044539 , 14044577 , 14044896 , 14044909 , 14044993 , 14045120 , 14045176 , 14045177 , 14045186 , 14045952 , 14045976 , 14046019 , 14046154 , 14046698 , 14046700 , 14046781 , 14046822 , 14046827 , 14047258 , 14047805 , 18627447 , 18627450 , 18627451 , 18627452 , 18627455 , 18627459 , 18627460 , 18627461 , 18627462 , 18627464 , 18627466 , 18627467 , 18627475 , 18627490 , 18627495 , 18627502 , 18627505 , 18627508 , 18627554 , 18627572 , 18627573 , 18627607 , 18627704 , 18627710 , 18627711 , 18627714 , 18627715 , 18627720 , 18627725 , 18627731 , 18627732 , 18627733 , 18627761 , 18627762 , 18627765 , 18627766 , 18627767 , 18627783 , 18627784 , 18627787 , 18627870 , 18627872 , 18627876 , 18627882 , 18627891 , 18627917 , 18627928 , 18627935 , 18627939 , 18627942 , 18627944 ,…
FDA’s list runs to 2,125 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.
Worldwide Distribution - USA including AK, AL, AR, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, District of Columbia, Puerto Rico and Brazil, Canada, Colombia, Ecuador, France, Israel, Italy, Mexico, Oman, Peru, Saudi Arabia, Spain, Turkey, United Arab Emirates, United Kingdom, and Venezuela.
The states and territories these words name
50 states and territories.
Every one of them
- Alaska
- Alabama
- Arkansas
- California
- Colorado
- Connecticut
- District of Columbia
- Delaware
- Florida
- Georgia
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Puerto Rico
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
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 Jul 2, 2014.
- FDA classified it on Feb 23, 2015.
- FDA’s Enforcement Report published it on Mar 4, 2015.
- FDA terminated it on May 24, 2017.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Hospira Inc., 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 2,125 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.