# K103224: Hospira Plum Infusion Set; Hospira Infusion Set with Yellow Stripe Tubing

- Pathway: 510(k) (Special)
- Applicant: Hospira, Inc.
- Decided: Jan 7, 2011 after 67 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 3 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K011442 (2001). 10 ancestors in all.
10 later devices descend from it; 1 cites it directly.
9 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052052: Hospira Plum a+ Infusion Pump System V11.5, Hospira Plum a+ 3 Infusion Pump System, V11.5, Hospira, Inc. (2005) Summary page 1.
- K982159: Abbott Plum a+ Infusion Pump, Abbott Laboratories (1999) Summary page 1.
- K060806: Hospira Gemstar Infusion Pump System, 7 Therapy, Model 13087; 6 Therapy, Model 13086; Pain Management, Model 13088, Hospira, Inc. (2006) Summary page 1.

## Most influential descendants
- K141789: Plum 360 Infusion System with Hospira Mednet, Smart Card Plug N Play CE 3.0 Module for Plum a+ Infusion System Upgrade (2015), 9 descendants of its own
- K161469: Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module (2017), 5 descendants of its own
- K223607: Plum Duo™ Infusion System (2023), 2 descendants of its own
- K153074: Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo Connect Portal (2016), 2 descendants of its own
- K183311: Ivenix Infusion System (IIS) (2019), 1 descendant of its own

## Recalls of this device
- Sep 9, 2013 · Class II · Z-2058-2016: Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets.
- Apr 1, 2013 · Class I · Z-1856-2013: It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of the pin into the blood bag.
- Mar 28, 2011 · Not classified · Z-2027-2011: There is a potential for the air filter at the distal end of the set to become detached. This could result in the contamination of the sterile fluid path inside the tubing.

## Indications for use
Hospira infusion sets are intended for use in parenteral, enteral and epidural therapies and the administration of fluids, medications, nutritional fluids, blood and blood products. Safety features on these devices aid in prevention of needle-stick injuries. Indications for use may include hospital and other medical settings, ambulatory and home use.

Source page: https://510kreport.com/device/K103224
Methodology: https://510kreport.com/methodology