Recall Z-2874-2016— Hospira Inc.

Name: FDA recall Z-2874-2016
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: K042800. Product: LifeCare PCA 3, PCA Serial List Number 12384 Allows for clinician administration or self-administration of analgesic medications.. Reason: Screw rotation error occurring when the pump detects a mismatch between the number of steps given to the motor driving delivery and the number of steps the motor actually took. When this malfunction occurs, the pump will alarm and infusion stops..

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

K042800 — LIFECARE PCA INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWAREHospira, Inc.·cleared 2004-10-18

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

LifeCare PCA 3, PCA Serial List Number 12384 Allows for clinician administration or self-administration of analgesic medications.

Reason for recall

Screw rotation error occurring when the pump detects a mismatch between the number of steps given to the motor driving delivery and the number of steps the motor actually took. When this malfunction occurs, the pump will alarm and infusion stops.

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