Recall Z-2724-2016— Hospira Inc.

Name: FDA recall Z-2724-2016
Creator: U.S. Food and Drug Administration
Published: 2013-02-06

Class II · Terminated

Class II FDA medical device recall by Hospira Inc., initiated 2013-02-06, terminated 2016-11-14. It names one FDA 510(k) clearance: K081412. Product: Plum A+ Infusion Pump. List Number 11973. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self-contained, microprocessor based infusion devices.. Reason: The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of therapy..

Recalling firm: Hospira Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-02-06
Terminated: 2016-11-14
Firm location: Lake Forest, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K081412 — PLUM A+ HYPERBARIC INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWAREHospira, Inc.·cleared 2008-12-17

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

Plum A+ Infusion Pump. List Number 11973. The Plum A+ Infusion Systems are a multi-purpose family of devices that provides precise delivery of multiple therapies across the general spectrum of clinical care. The Plum A+ family infusion pumps are self-contained, microprocessor based infusion devices.

Reason for recall

The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of therapy.

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