25

Oct

2017

Alaris Pump Module model 8100 Cl II

infusionpump, recall

0

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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About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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