FDA Medical Device Recalls (openFDA)
CareFusion 303, Inc.: Alaris PC unit model 8015. The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System.
- Recall number
- Z-0876-2012
- Recalling firm
- CareFusion 303, Inc.
- Product
- Alaris PC unit model 8015. The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System.
- Status
- Terminated
- Initiated
- 2011-09-13
- Posted
- 2012-01-26
- Terminated
- 2012-01-31
- Reason
- The recall was initiated because Carefusion has identified a potential risk with a PLD component on the Alaris PC unit model 8015 power supply board. The PLD component used in production between June 21, 2011 and August 15, 2011 has a higher standby current resulting in the battery depleting prematurely.
- Root cause
- Nonconforming Material/Component
- Action
- Carefusion sent an "URGENT: MEDICAL DEVICE RECALL NOTIFICATION" letter dated September 13, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. A Customer Reply Card was enclosed for customers to complete and return to the firm. Customers were instructed to call Carefusion Support Center at (888) 562-6018, 7 am-5 pm (Pacific) for any recall related questions.
- Quantity
- 1039 units
- Distribution
- Worldwide Distribution-USA (nationwide) including the states of AZ, CA, CT, FL, IA, IL, MI, MO, NJ, NY, OH, SC, SD, and TX. and the country of Australia.
- Lot, serial or model codes
- The affected units have unique serial numbers for traceability.
- 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