06
Jul
2016

Alaris System PC Unit Model 8015 Cl II

0

Company: CareFusion 303 Inc.
Date of Enforcement Report 7/6/2016
Class lI:

PRODUCT

Alaris System PC Unit Model 8015 with software versions 9.17 and 9.19; Central programming, monitoring and power supply component for the Alaris System.
Recall Number Z-2064-2016

REASON
A patient weight can be populated incorrectly under certain conditions when using the RESTORE feature to restore infusions running on the Alaris LVP module model 8100 and the Alaris Syringe module model 8110.

RECALLING FIRM/MANUFACTURER
CareFusion 303, Inc., San Diego, CA on 5/12/2016. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
69,693 units

DISTRIBUTION
Nationwide and Canada

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About the author

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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