FDA Medical Device Recalls (openFDA)
CareFusion 303, Inc.: Alaris PC Unit, Model 8015
- Recall number
- Z-2671-2017
- Recalling firm
- CareFusion 303, Inc.
- Product
- Alaris PC Unit, Model 8015
- Status
- Terminated
- Initiated
- 2017-06-12
- Posted
- 2017-06-19
- Terminated
- 2018-10-26
- 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.
- Root cause
- Software design
- 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 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
- 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.
- Lot, serial or model codes
- Notification will be distributed to all Alaris PC Unit model 8015 customers with software versions greater than 9.12.
- 510(k) numbers
- ["K051641"]
- PMA numbers
- not on file
- Product code
- FRN
- Firm FEI
- 2016493
- Firm city
- San Diego
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28