Recall Z-2139-2016— Hospira Inc.

Name: FDA recall Z-2139-2016
Creator: U.S. Food and Drug Administration
Published: 2013-03-08

Class II · Terminated

Class II FDA medical device recall by Hospira Inc., initiated 2013-03-08, terminated 2016-11-07. It names one FDA 510(k) clearance: K912928. Product: The LifeCare PCA Plus II infusion pump system is designed for safe, effective, analgesic delivery to patients through the intravenous or epidural routes in a wide range of clinical settings, including ICU, CCU, SICU, trauma units, bone marrow transplant centers, burn units, oncology centers, and medical/surgical nursing units.. Reason: 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 that travels up and down the lead screw) which prevents it from properly detecting the pressure build-up associated with a distal occlusion..

Recalling firm: Hospira Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-03-08
Terminated: 2016-11-07
Firm location: Lake Forest, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K912928 — LIFECARE 4100 PCA INFUSER PLUS IIAbbott Laboratories·cleared 1991-08-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

The LifeCare PCA Plus II infusion pump system is designed for safe, effective, analgesic delivery to patients through the intravenous or epidural routes in a wide range of clinical settings, including ICU, CCU, SICU, trauma units, bone marrow transplant centers, burn units, oncology centers, and medical/surgical nursing units.

Reason for recall

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 that travels up and down the lead screw) which prevents it from properly detecting the pressure build-up associated with a distal occlusion.

Data sourced from openFDA. This site is unofficial and independent of the FDA.