29
Mar
2017

Cl II Alaris System PC unit

,
0

Company: CareFusion 303, Inc.
Date of Enforcement Report 3/29/2017
Class lI:

PRODUCT

Alaris System PC unit, model no. 8000 and 8015. The central programming, monitoring and power supply component for the Alaris infusion pump System.
Recall Number Z-1520-2017

REASON
Reports where the Low Battery alarm and/or the Very Low Battery alarm are not being triggered before the battery is discharged and all infusion channels are stopped

RECALLING FIRM/MANUFACTURER
CareFusion 303, Inc., San Diego, CA on 11/1/2016. Voluntary: Firm Initiated recall is ongling.

VOLUME OF PRODUCT IN COMMERCE
613,800 total units (575,221 units in US)

DISTRIBUTION
Nationwide and Internationally.

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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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