PlainRecalls
FDA Devices Moderate Class II Ongoing

Alaris Pump Module model 8100 manufactured between November 2011 and March 2012; Alaris Pump Module serviced with LVP Mechanism Sub Assembly (P/N) 10942012 between November 2011 and March 2012; Alaris Pump module Bezel Kit Assembly (P/N) 10964559) shipped between November 2011 and March 2012. The Alaris Pump module is a large volume infusion pump offered under the Alaris System. The Alaris Pump module will deliver medication and fluids using the IV administration sets for continuous or

Reported: October 25, 2017 Initiated: August 9, 2017 #Z-0026-2018

Product Description

Alaris Pump Module model 8100 manufactured between November 2011 and March 2012; Alaris Pump Module serviced with LVP Mechanism Sub Assembly (P/N) 10942012 between November 2011 and March 2012; Alaris Pump module Bezel Kit Assembly (P/N) 10964559) shipped between November 2011 and March 2012. The Alaris Pump module is a large volume infusion pump offered under the Alaris System. The Alaris Pump module will deliver medication and fluids using the IV administration sets for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous or epidural.

Reason for Recall

The recalling firm has received reports of increased or decreased flows that have occurred in certain pumps.

Details

Recalling Firm
CareFusion 303, Inc.
Units Affected
31,622 units (28,224 in US)
Distribution
Worldwide Distribution - USA (nationwide) and to the countries of : Canada, Australia, UAE, Kuwait, Saudi Arabia, South Africa
Location
San Diego, CA

Frequently Asked Questions

What product was recalled? ▼
Alaris Pump Module model 8100 manufactured between November 2011 and March 2012; Alaris Pump Module serviced with LVP Mechanism Sub Assembly (P/N) 10942012 between November 2011 and March 2012; Alaris Pump module Bezel Kit Assembly (P/N) 10964559) shipped between November 2011 and March 2012. The Alaris Pump module is a large volume infusion pump offered under the Alaris System. The Alaris Pump module will deliver medication and fluids using the IV administration sets for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous or epidural.. Recalled by CareFusion 303, Inc.. Units affected: 31,622 units (28,224 in US).
Why was this product recalled? ▼
The recalling firm has received reports of increased or decreased flows that have occurred in certain pumps.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 25, 2017. Severity: Moderate. Recall number: Z-0026-2018.

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