Cl II Alaris PC units infusion pumps

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.

___________________________________

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.