Company:Beckman Coulter Inc..
Date of Enforcement Report 10/25/2017
Class lI:
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
Recall Number Z-0026-2018
REASON
The recalling firm has received reports of increased or decreased flows that have occurred in certain pumps
RECALLING FIRM/MANUFACTURER
CareFusion 303, Inc, San Diego CA on 8/9/2017. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
31,622 units (28,224 in US)
DISTRIBUTION
Nationwide and Internationally
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