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U.S. Department of Health and Human Services

Class 2 Device Recall Alaris PC Unit, Model 8015

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 Class 2 Device Recall Alaris PC Unit, Model 8015see related information
Date Initiated by FirmJune 12, 2017
Date PostedJune 19, 2017
Recall Status1 Terminated 3 on October 26, 2018
Recall NumberZ-2671-2017
Recall Event ID 77077
510(K)NumberK051641 
Product Classification Pump, infusion - Product Code FRN
ProductAlaris PC Unit, Model 8015
Code Information Notification will be distributed to all Alaris PC Unit model 8015 customers with software versions greater than 9.12.
Recalling Firm/
Manufacturer		 CareFusion 303, Inc.
10020 Pacific Mesa Blvd
San Diego CA 92121-4386
For Additional Information ContactMichelle Badal
858-617-5925
Manufacturer 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.
FDA Determined
Cause 2		Software design
ActionBD 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 supportcenter@carefusion.com. Customers with adverse event reports are instructed to call (888) 812-3266 or email customerfeedback@carefusion.com. Customers with technical questions are instructed to call (888) 812-3229 or email dl-us-inf-techsupport@carefusion.com. For further questions, please call (858) 617-5925.
Quantity in Commerce568,283 units
DistributionWorldwide Distribution - USA (nationwide) and to the countries of : Europe, Australia, New Zealand, South Africa, Greater Asia, Middle East, and Canada.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = FRN
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