Company:CareFusion 303, Inc.
Date of Enforcement Report 7/12/2017
Class lI:
PRODUCT
Alaris PC Unit, Model 8015
Recall Number Z-2671-2017
REASON
BD initiated the recall of Alaris PC unit model 8015 after the firm identified five scenarios which can result in the occurrence of Systems Error Code 255-16-275 and can potentially result in interrupted infusions.
RECALLING FIRM/MANUFACTURER
CareFusion 303, Inc., San Diego, CA on 6/12/2017. Voluntary: Firm Initiated recall is ongling.
VOLUME OF PRODUCT IN COMMERCE
568,283 units
DISTRIBUTION
Worldwide Distribution – USA (nationwide) and to the countries of : Europe, Australia, New Zealand, South Africa, Greater Asia, Middle East, and Canada.
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