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CareFusion 303, Inc. recalls Alaris Pump Module model 8100 manufactured between November 2011 and March 2012; Alaris Pump Module serviced with LVP
Recalled October 25, 2017 · FDA recall Z-0026-2018 · CareFusion 303
Hazard
The recalling firm has received reports of increased or decreased flows that have occurred in certain pumps. · FDA Class II
Units
31,622 units (28,224 in US)
Sold at
Worldwide Distribution - USA (nationwide) and to the countries of : Canada, Australia, UAE, Kuwait, Saudi Arabia, South Africa
Description
The recalling firm has received reports of increased or decreased flows that have occurred in certain pumps.
Product
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.
Manufacturer(s)
CareFusion 303, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →