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  1. Recalls (Biologics)

Voluntary Medical Device Customer Notification – Vista Information System

DATE NOTIFICATION INITIATED:  December 15, 2017

PRODUCT:  Vista Information System (version 4)

MANUFACTURER: 

TERUMOBCT
Lakewood, CO

REASON: 

TERUMOBCT is notifying customers of an issue related to using Vista Information System version 4.  There is a specific condition that will cause messages not to be displayed in the Product Message tab for a completed, Vista-controlled procedure on the Trima Accel Automated Blood Collection System.

As a result of the condition, there is a potential risk that the resulting product could be incorrectly labeled.  The risk of incorrectly labeling a transfusion product as leukoreduced is low because product messages, if not displayed in Vista, are available from three other sources.  Healthcare providers and distributors are asked to follow TERUMOBCT’s notification instructions.

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The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA.  Its accuracy and comprehensiveness cannot be guaranteed.