Alaris PC Unit, Model 8015 recallZ-2671-2017 · CareFusion 303, Inc. · initiated Jun 12, 2017
Class II Terminated All recalls posted in June 2017
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from CareFusion 303, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Software design
What the company is doing
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.
Recall details
- Recall number
- Z-2671-2017
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jun 12, 2017
- Posted by the FDA
- Jun 19, 2017
- Recalling firm
- CareFusion 303, Inc.
- Quantity
- 568,283 units
- Product code
- FRN
- FDA submissions
- K051641
- Distribution
- Worldwide Distribution - USA (nationwide) and to the countries of : Europe, Australia, New Zealand, South Africa, Greater Asia, Middle East, and Canada.
Product description
Alaris PC Unit, Model 8015
Code information (models, lots, serial numbers)
Notification will be distributed to all Alaris PC Unit model 8015 customers with software versions greater than 9.12.
Other devices under the same FDA submission
1 device cleared under K051641 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Alaris 8015Carefusion 303, Inc. · Pump, infusion2 recalls45 deaths148,093 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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