# K043256: Hospira Lifecare Infusion System, Model 12384-04-07; Lifecare Pca Infusion System Sterile Empy Vials, Model 6021-04-03

- Pathway: 510(k) (Special)
- Applicant: Hospira, Inc.
- Decided: Dec 6, 2004 after 12 days
- Product code: MEA (Pump, Infusion, Pca)
- 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: 4 generations back to K011442 (2001). 7 ancestors in all.
1 later device descends from it; 1 cites it directly.
2 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042800: Lifecare Pca Infusion System with Hospira Mednet Software, Hospira, Inc. (2004) Summary page 2.
- K022203: Abbott Lifecare Pca 3 Infuser, Model 12384, Abbott Laboratories (2002) Summary page 2.

## Most influential descendants
- K143612: LifeCare PCA Infusion System (2016), 0 descendants of its own

## Recalls of this device
- Mar 8, 2013 · Class II · Z-2140-2016: Hospira has received reports of PCA pumps not detecting distal occlusions, one of which resulted in a serious injury. The issue is caused by normal wear and tear on the Half Nut (the component/nut tha
- Feb 27, 2013 · Class II · Z-1517-2015: The infusion pump has a clear plastic door that, due to its design, allows for excessive flexing. This in turn permits unauthorized access to the vial of medication.
- Aug 2, 2012 · Class II · Z-2346-2012: Reports of leaking during filling and administration.
- Nov 2, 2005 · Not classified · Z-0601-06: Incorrect values for dosage, dose limit, concentration or rate of delivery may display on screen.

## Indications for use
The Hospira LifeCare® PCA3 Infusion System is indicated for accurate, volumetric, infusion of analgesic drugs by continuous or patient-demanded (PCA) intravenous administration. The LifeCare PCA® Infusion System is also indicated for short-term (less than 96 hours) continuous epidural administration of analgesic drugs.

Source page: https://510kreport.com/device/K043256
Methodology: https://510kreport.com/methodology