Jun

2015

Cl II CareFusion Alaris PC unit model 8015

Company: CareFusion 303, Inc.
Date of Enforcement Report 6/24/2015
Class lI:

PRODUCT

Alaris PC unit model 8015, software version 9.17 Infusion Pump. Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. The software is embedded in the Alaris PC unit.
Recall Number Z-1811-2015

REASON
CareFusion has identified an issue with the Alaris PC unit model 8015 software version 9.17 related to the cancel functionality that be used during atypical infusion programming to cancel user inputted values.

RECALLING FIRM/MANUFACTURER
CareFusion 303, Inc., San Diego, CA on 5/13/2015. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
63 units

DISTRIBUTION
Nationwide

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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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Cl II CareFusion Alaris PC unit model 8015

Amy Sellers

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