Cl II CareFusion Alaris PC unit model 8015

Company: CareFusion 303, Inc.
Date of Enforcement Report 6/24/2015
Class lI:

PRODUCT

Alaris PC unit model 8015, software version 9.17 Infusion Pump. Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. The software is embedded in the Alaris PC unit.
Recall Number Z-1811-2015

REASON
CareFusion has identified an issue with the Alaris PC unit model 8015 software version 9.17 related to the cancel functionality that be used during atypical infusion programming to cancel user inputted values.

RECALLING FIRM/MANUFACTURER
CareFusion 303, Inc., San Diego, CA on 5/13/2015. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
63 units

DISTRIBUTION
Nationwide

___________________________________

Schedule Discussion with John F. Murray, Jr.

John is currently providing telephone and face-to-face meetings to discuss:  Cybersecurity, Part 11, 483 Response, design controls expectations for software documentation, and other topics.

Leave a message and we will contact you to schedule:

Corporate Office

+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TN) and Italy.