Mar

2016

Infusion Pump: Cl II Alaris PC Unit

Company: CareFusion 303 Inc..
Date of Enforcement Report 3/30/2016
Class lI:

PRODUCT

Alaris PC Unit, Infusion Pump Model 8000, Part No. TC10005092.
Recall Number Z-1239-2016

REASON
CareFusion is recalling the Alaris PC unit because a component on the PC unit power supply may cause a “System Error” or “Missing Battery” error code (120.4630).

RECALLING FIRM/MANUFACTURER
CareFusion 303, Inc., San Diego, CA on 2/24/2016. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
170 units

DISTRIBUTION
Nationwide

___________________________________

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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Infusion Pump: Cl II Alaris PC Unit

Amy Sellers

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