FDA-Device2017-10-25Class II
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
CareFusion 303, Inc.
Hazard
The recalling firm has received reports of increased or decreased flows that have occurred in certain pumps.
Sold states
Worldwide Distribution - USA (nationwide) and to the countries of : Canada, Australia, UAE, Kuwait, Saudi Arabia, South Africa
Affected count
31,622 units (28,224 in US)
Manufactured in
10020 Pacific Mesa Blvd, San Diego, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0026-2018Don't want to check this manually?
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