Jan

2014

Class l Alaris PC unit model 8000 and 8015

Company:CareFusion 303, Inc..
Date of Enforcement Report:1/1/2014
Class l:

PRODUCT

Alaris PC unit model 8000 and 8015 with Alaris PCA module model 8120 and Auto ID barcode scanner model 8600. Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. The Alaris PCA (Patient Controlled Analgesia) pump is one of the modules offer under the Alaris System. The Auto ID is a barcode scanner. Recall Number Z-0534-2014

REASON
CareFusion is recalling the Alaris PC unit (model 8000 and 8015) because the Alaris PC unit will produce an audible alarm and the Alaris PC unit will display a System Error message..

RECALLING FIRM/MANUFACTURER
CareFusion 303, Inc.San Diego, CA on 12/5/2013. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
4824 total units (4242 units in US)

DISTRIBUTION
Nationwide andI 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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Class l Alaris PC unit model 8000 and 8015

Amy Sellers

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