FDA Medical Device Recalls (openFDA)
CareFusion 303, Inc.: Alaris System PC unit, model no. 8000 and 8015. The central programming, monitoring and power supply component for the Alaris infusion pump System.
- Recall number
- Z-1520-2017
- Recalling firm
- CareFusion 303, Inc.
- Product
- Alaris System PC unit, model no. 8000 and 8015. The central programming, monitoring and power supply component for the Alaris infusion pump System.
- Status
- Terminated
- Initiated
- 2016-11-01
- Posted
- not on file
- Terminated
- 2020-04-24
- Reason
- Reports where the Low Battery alarm and/or the Very Low Battery alarm are not being triggered before the battery is discharged and all infusion channels are stopped.
- Root cause
- Use error
- Action
- A customer letter dated 11/1/2016 will be sent to all customers to inform them that BD has identified an issue with the Alaris System PC unit. The letter informs the customers that BD has received reports for the Alaris PC units where the Low Battery alarm and/or the Very Low Battery alarm are not being triggered before the battery is discharged and all infusion channels are stopped. The letter informs the customers of the issue and recommended steps to take. Customers with recall related questions are instructed to contact BD Support Center at (888) 562-6018, 7-4pm PT, M-F, supportcenter@carefusion.com. Customers with adverse event reports are instructed to contact Customer Advocacy at (888) 812-3266, 24hrs/day, 7days/wk, customerfeedback@carefusion.com. Customers with technical questions regarding the Alaris System are instructed to contact Technical Support at (888) 812-3229, 6am-5pm PT, M-F, DL-US-INF-TechSupport@carefusion.com.
- Quantity
- 613,800 total units (575,221 units in US)
- Distribution
- Worldwide distribution. US nationwide, Europe, Australia, New Zealand, South Africa, Greater Asia, Middle East, and Canada.
- Lot, serial or model codes
- all units
- 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