# K031185: Abbott Plum a+ Infusion Pump with a HPL/RS Plug-and-Play Module

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Apr 30, 2003 after 15 days
- Product code: FRN (Pump, Infusion)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K011442 (2001). 2 ancestors in all.
32 later devices descend from it; 2 cite it directly.
14 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011442: Abbott Plum a+Infusion Pump, Model 11971, Abbott Laboratories (2001)
- K024084: Abbott Plum a+ Infusion Pump, Model 12391, Abbott Laboratories (2002) Summary page 1.

## Most influential descendants
- K042081: Plum a+ Infusion System with Hospira Mednet Software , and Plum a+3 Infusion System with Hospira Mednet Software (2004), 27 descendants of its own
- K041550: Hospira Phoenix Infusion System with Hospira Mednet Software (2004), 13 descendants of its own
- K052052: Hospira Plum a+ Infusion Pump System V11.5, Hospira Plum a+ 3 Infusion Pump System, V11.5 (2005), 12 descendants of its own
- K103224: Hospira Plum Infusion Set; Hospira Infusion Set with Yellow Stripe Tubing (2011), 10 descendants of its own
- K103344: Infusion Sets (2010), 10 descendants of its own

## Recalls of this device
- Oct 26, 2012 · Class II · Z-0481-2013: 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
- Sep 16, 2011 · Not classified · Z-0010-2012: 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
- Sep 16, 2011 · Not classified · Z-3285-2011: 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
- Feb 14, 2011 · Not classified · Z-1645-2011: 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 iss

## Indications for use
Indicated for use in parenteral, enteral and epidural therapies and the administration of whole blood and blood products.

Source page: https://510kreport.com/device/K031185
Methodology: https://510kreport.com/methodology