Cl II Alaris System PC unit

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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