01
Apr
2015

Cl II Alaris PC units infusion pumps

,
0

Company:CareFusion 303, Inc.
Date of Enforcement Report: 4/1/2015
Class lI:

PRODUCT

Alaris PC units, Model No. 8015. Infusion pump.
Recall Number Z-1311-2015

REASON
CareFusion is recalling the Alaris PC unit because of an error code. The error code may occur upon power on during the “Power-On Self Test” due to a keypad issue.

RECALLING FIRM/MANUFACTURER
CareFusion 303, Inc., San Diego, CA on 3/12/2015 Voluntary: Firm Initiated recall is ongoing

VOLUME OF PRODUCT IN COMMERCE
56,015 units

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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