Recall Z-1072-2015— Hospira Inc.

Name: FDA recall Z-1072-2015
Creator: U.S. Food and Drug Administration
Published: 2014-07-02

Class I · Terminated

Class I FDA medical device recall by Hospira Inc., initiated 2014-07-02, terminated 2017-05-24. It names one FDA 510(k) clearance: K070398. Product: The Plum A+ Infusion System is designed to meet the fluid delivery requirements of today's evolving healthcare environments. It is a cassette based multi-function infusion system. The Plum A+ allows two lines in and one line out. The pump can be used for standard, piggyback, or concurrent delivery. Therapy modes include: Standard Infusions, Multistep Programming, Loading Dose, and Dose Calculation. The Plum A+ is designed to deliver parenteral, enteral, or epidural infusions over a broad range of infusion rates from multiple fluid container types. Each system includes a pumping module and an assortment of disposable IV sets, optional accessories, and an operator's manual.. Reason: One lot of alarm assemblies used in Plum A+ and Plum A+3 infusion pumps may fail to sound at all volume levels..

Recalling firm: Hospira Inc.
Classification: Class I
Status: Terminated
Initiated: 2014-07-02
Terminated: 2017-05-24
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 designed to meet the fluid delivery requirements of today's evolving healthcare environments. It is a cassette based multi-function infusion system. The Plum A+ allows two lines in and one line out. The pump can be used for standard, piggyback, or concurrent delivery. Therapy modes include: Standard Infusions, Multistep Programming, Loading Dose, and Dose Calculation. The Plum A+ is designed to deliver parenteral, enteral, or epidural infusions over a broad range of infusion rates from multiple fluid container types. Each system includes a pumping module and an assortment of disposable IV sets, optional accessories, and an operator's manual.

Reason for recall

One lot of alarm assemblies used in Plum A+ and Plum A+3 infusion pumps may fail to sound at all volume levels.

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