510(k) · Cleared
Recalled · Class I · 2024Hospira Plum a+ Infusion Pump, Model 12391
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hospira, Inc. · FRN Pump, Infusion
Cleared on Apr 24, 2007 as substantially equivalent to K052052 (Hospira, Inc., 2005) and 1 other predicate after a 71-day review. Its family tree reaches back 4 generations to 2001. 4 of the 7 devices in its family, counting itself, have a Class I recall. It has been recalled 21 times, including 4 Class I recalls.
- Decided
- Apr 24, 2007
- Review
- 71 days
- Class
- Class II
- Product code
- FRN
- Recalls
- 21 (4 Class I)
- Predicates
- 2
Its longest line of descent runs back 4 generations to K011442 (2001). 6 ancestors in all. No later device cites it as a predicate yet. 4 of the 7 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK011442 Abbott Plum a+Infusion Pump, Model 11971Abbott Laboratories · 2001 · Recalled (Class I)
- 3 generations backK031185 Abbott Plum a+ Infusion Pump with a HPL/RS Plug-and-Play ModuleAbbott Laboratories · 2003 · Recalled
- 2 generations backK042081 Plum a+ Infusion System with Hospira Mednet Software , and Plum a+3…Hospira, Inc. · 2004 · Recalled (Class I)
- 1 generation backK052052 Hospira Plum a+ Infusion Pump System V11.5, Hospira Plum a+ 3…Hospira, Inc. · 2005 · Recalled (Class I)
- This deviceK070398 Hospira Plum a+ Infusion Pump, Model 12391Hospira, Inc. · 2007
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K011442 | Abbott Plum a+Infusion Pump, Model 11971 | Abbott Laboratories | 2001 | Class I |
| −3 | K031185 | Abbott Plum a+ Infusion Pump with a HPL/RS Plug-and-Play Module | Abbott Laboratories | 2003 | 4 |
| −2 | K042081 | Plum a+ Infusion System with Hospira Mednet Software , and Plum a+3 Infusion… | Hospira, Inc. | 2004 | Class I |
| −1 | K052052 | Hospira Plum a+ Infusion Pump System V11.5, Hospira Plum a+ 3 Infusion Pump… | Hospira, Inc. | 2005 | Class I |
| 0 (this device) | K070398 | Hospira Plum a+ Infusion Pump, Model 12391 | Hospira, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
4 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FRN device
- #1 K253703 RemunityPRO+ Pump for Remodulin®…score 12.6 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K052052 | Hospira Plum a+ Infusion Pump System V11.5, Hospira Plum a+ 3 Infusion Pump System, V11.5Summary page 1…Product code FRN 4. Trade Name of Proposed Device: Plum A+ ® Infusion Pump, 5. Predicate Devices: K052052 Hospira Plum A+ Infusion Pump System v 1 Cleared 08/24/2005… | 2005 |
| * | K024084 | Abbott Plum a+ Infusion Pump, Model 12391Summary page 1…K052052 Hospira Plum A+ Infusion Pump System v 1 Cleared 08/24/2005 K024084 Abbott Plum A- Infusion Pump, Model 12391 Cleared 12/31/2002 6. Manufacturer and Est… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (4 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 7, 2024 | Class I | Z-2448-2024 | Process control | Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and overall battery runtime may decrease earlier in the battery lifecycle than… |
| May 7, 2024 | Class I | Z-2449-2024 | Process control | Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and overall battery runtime may decrease earlier in the battery lifecycle than… |
| Mar 22, 2023 | Class I | Z-1566-2023 | Under Investigation by firm | Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and overall battery runtime may decrease earlier in the battery lifecycle than… |
| Jul 2, 2014 | Class I | Z-1072-2015 | Component change control | One lot of alarm assemblies used in Plum A+ and Plum A+3 infusion pumps may fail to sound at all volume levels. |
| Feb 1, 2013 | Class II | Z-0287-2014 | Component design/selection | Plum A+ infusers have the potential for the distal (occlusion) press sensor pin to break. The distal pressure sensor pin is a part of the overall subsystem that measures the pressure within the distal line of the administration set and… |
| Feb 1, 2013 | Class II | Z-2681-2017 | Other | A possible interruption of therapy when an E321 error code occurs while using the infuser, which is caused by battery issues. |
| Feb 1, 2013 | Class II | Z-2683-2017 | Other | A possible interruption of therapy when an E321 error code occurs while using the infuser, which is caused by battery issues. |
| Feb 1, 2013 | Class II | Z-2675-2017 | Other | A possible interruption of therapy when an E321 error code occurs while using the infuser, which is caused by battery issues. |
| Feb 1, 2013 | Class II | Z-2678-2017 | Other | A possible interruption of therapy when an E321 error code occurs while using the infuser, which is caused by battery issues. |
| Feb 1, 2013 | Class II | Z-2680-2017 | Other | A possible interruption of therapy when an E321 error code occurs while using the infuser, which is caused by battery issues. |
| Feb 1, 2013 | Class II | Z-2677-2017 | Other | A possible interruption of therapy when an E321 error code occurs while using the infuser, which is caused by battery issues. |
| Feb 1, 2013 | Class II | Z-2679-2017 | Other | A possible interruption of therapy when an E321 error code occurs while using the infuser, which is caused by battery issues. |
| Feb 1, 2013 | Class II | Z-2676-2017 | Other | A possible interruption of therapy when an E321 error code occurs while using the infuser, which is caused by battery issues. |
| Feb 1, 2013 | Class II | Z-2682-2017 | Other | A possible interruption of therapy when an E321 error code occurs while using the infuser, which is caused by battery issues. |
| Dec 7, 2012 | Class II | Z-0624-2013 | Device Design | The door roller assembly on the Plum A+/A+3 infuser family of infusers has the potential to break which can lead to possible unrestricted flow and/or over-delivery during the removal of the IV administration set's cassette from the pump. |
| Oct 26, 2012 | Class II | Z-0481-2013 | Device Design | The volume control knob on some Plum A+ single channel infusers (located on the back of the infuser) may not function as described in the System Operating Manual - the direction for Loud and Quiet may be reversed. The manual indicates a… |
| Feb 5, 2012 | Class II | Z-0207-2014 | Nonconforming Material/Component | Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The following error codes may be displayed during setup or infusion signifying possible calibration drift: E180/N180, E181/N181, E186/N186… |
| Sep 16, 2011 | Not classified | Z-0009-2012 | Software design | Hospira has received reports of continuous recycling and/or rebooting of Plum A+ infusion pumps when the backlight intensity and/or display contrast settings for the LED display has been adjusted from the original default setting. This… |
| Sep 16, 2011 | Not classified | Z-3284-2011 | Nonconforming Material/Component | Hospira has received reports of incorrect seating of the regulator closer on the Plum A+ Infusion Pumps. If the regulator closer does not close the flow regulator actuator when the pump door is opened, and if the clinician has not engaged… |
| Feb 14, 2011 | Not classified | Z-1644-2011 | Nonconforming Material/Component | Hospira has received customer reports of the Plum A+ infusion pumps with no audible alarm conditions, which have been associated with failure of the piezoelectric assembly due to component quality issues. |
| Aug 11, 2009 | Not classified | Z-0024-2010 | Component design/selection | Fire/Shock hazard-- A component used in the device may cause sparks/flashes and poses a fire and shock hazard. |
The 5 latest of 21 recalls; the web page lists all.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K052052Hospira Plum a+ Infusion Pump System V11.5, Hospira Plum a+ 3 Infusion Pump System, V11.5Hospira, Inc. · 2005 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K042081Plum a+ Infusion System with Hospira Mednet Software , and Plum a+3 Infusion System with Hospira Mednet…Hospira, Inc. · 2004 · 2 generations back · ◆ on the line of descent in FIG. 14 Class I recalls
- K011442Abbott Plum a+Infusion Pump, Model 11971Abbott Laboratories · 2001 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 1.7 years on median.
- 5 of the 6 ancestors have a recall of any class; 3 have a Class I recall.
- 1 other device also cites its predicate K052052.
How does its category compare?
All FRN devicesFRN Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · FRN
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRN
172in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRN
7in 2025
Class I (37 since 2007) Class II/III not classified
Adverse event reports per year · FRN
52,792in 2025
MAUDE reports naming product code FRN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 12 | 102 | 15 | 1,086 |
| 2008 | 8 | 89 | 24 | 8,261 |
| 2009 | 9 | 66 | 102 | 1,952 |
| 2010 | 3 | 93 | 37 | 6,133 |
| 2011 | 3 | 103 | 69 | 41,367 |
| 2012 | 4 | 217 | 42 (2) | 15,482 |
| 2013 | 6 | 312 | 22 (3) | 40,082 |
| 2014 | 6 | 172 | 4 (3) | 94,180 |
| 2015 | 3 | 232 | 5 | 26,742 |
| 2016 | 3 | 301 | 7 (1) | 16,560 |
| 2017 | 3 | 305 | 13 | 12,060 |
| 2018 | 3 | 267 | 1 | 16,591 |
| 2019 | 2 | — | 18 (1) | 15,850 |
| 2020 | 1 | — | 16 (5) | 94,186 |
| 2021 | 2 | — | 3 (2) | 199,342 |
| 2022 | 6 | 268 | 2 | 888,020 |
| 2023 | 7 | 265 | 16 (10) | 165,838 |
| 2024 | 5 | 103 | 9 (4) | 57,730 |
| 2025 | 8 | 172 | 7 (4) | 52,792 |
| 2026 | 2 | — | 11 (2) | — |
What is it indicated for?
Intended for use in parenteral, enteral, and epidural therapies and the
administration of whole blood and blood products
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070398 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070398: Hospira Plum a+ Infusion Pump, Model 12391.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070398
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026