Recall Z-0287-2014— Hospira Inc.

Name: FDA recall Z-0287-2014
Creator: U.S. Food and Drug Administration
Published: 2013-02-01

Class II · Terminated

Class II FDA medical device recall by Hospira Inc., initiated 2013-02-01, terminated 2016-12-06. It names one FDA 510(k) clearance: K070398. Product: The Plum A+ Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+ Infusion System is designed to deliver parenteral, enteral, or epidural infusions over a broad range of infusion rates from multiple fluid container types. The Plum A+ Infusion System includes an infuser, disposable IV sets (hereafter called a set), optional accessories, and this operator's manual. The Plum A+ Infusion System with Hospira MedNet Software is indicated for use in parenteral, enteral and epidural therapies and the administration of whole blood and blood products.. Reason: Plum A+ infusers have the potential for the distal (occlusion) press sensor pin to break. The distal pressure sensor pin is a part of the overall subsystem that measures the pressure within the distal line of the administration set and indicates the presence of a full or partial distal occlusion. A broken distal pin can only be detected via a visual inspection of the distal pressure pin. A broken.

Recalling firm: Hospira Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-02-01
Terminated: 2016-12-06
Firm location: Lake Forest, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K070398 — HOSPIRA PLUM A+ INFUSION PUMP, MODEL 12391Hospira, Inc.·cleared 2007-04-24

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 Plum A+ Infusion System is a cassette based multifunction infusion system that allows two lines in and one line out and can be used for standard, piggyback, or concurrent delivery. The Plum A+ Infusion System is designed to deliver parenteral, enteral, or epidural infusions over a broad range of infusion rates from multiple fluid container types. The Plum A+ Infusion System includes an infuser, disposable IV sets (hereafter called a set), optional accessories, and this operator's manual. The Plum A+ Infusion System with Hospira MedNet Software is indicated for use in parenteral, enteral and epidural therapies and the administration of whole blood and blood products.

Reason for recall

Plum A+ infusers have the potential for the distal (occlusion) press sensor pin to break. The distal pressure sensor pin is a part of the overall subsystem that measures the pressure within the distal line of the administration set and indicates the presence of a full or partial distal occlusion. A broken distal pin can only be detected via a visual inspection of the distal pressure pin. A broken

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