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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