Alaris PC Unit, Model 8015
FDA Recall Z-2671-2017 · Posted 2017-06-19
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Recalling FirmCareFusion 303, Inc.
Recall StatusTerminated
Product CodeFRN
Date Initiated2017-06-12
Date Terminated2018-10-26
Product Quantity568,283 units
Reason for Recall
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.
Firm Action
BD sent an Medical Device Safety Notification Letter dated June 12, 2017 , to customers to inform them that BD is issuing this Safety Notification letter to inform you of reports of customers experiencing a System Error (error code: 255-16-275) with Alaris System PC unit model 8015 that can result in interruption of infusions. Customers are informed of the issue, potential risk, and required actions to be taken by users and by BD. Customers with questions with the safety notification are instructed to call (888) 562-6018 or email [email protected]. Customers with adverse event reports are instructed to call (888) 812-3266 or email [email protected]. Customers with technical questions are instructed to call (888) 812-3229 or email [email protected]. For further questions, please call (858) 617-5925.
Root Cause
Software design
Distribution Pattern
Worldwide Distribution - USA (nationwide) and to the countries of : Europe, Australia, New Zealand, South Africa, Greater Asia, Middle East, and Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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