Z-0876-2012

Alaris PC unit model 8015. The Alaris PC unit is the central programming, monitoring and power supply...

Name: Z-0876-2012 Alaris PC unit model 8015. The Alaris PC unit is the central programming, monitoring and power supply...
Creator: CareFusion 303, Inc.
Published: 2011-09-13
License: https://open.fda.gov/license/

CareFusion 303, Inc / initiated 2011-09-13 / Terminated / root cause: manufacturing process

FDA source

CareFusion 303, Inc. began a recall of Alaris PC unit model 8015. The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System on 2011-09-13. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0876-2012
Status: Terminated
Initiated: 2011-09-13
Posted: 2012-01-26
Terminated: 2012-01-31
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.
Product code: FRN Pump, Infusion
Reason for recall: 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 tag: manufacturing process
FDA 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 in commerce: 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.
Product codes and lots: The affected units have unique serial numbers for traceability.

Product code FRN

K051641Class IIAlaris System Pc Unit, Model 8001Cardinal Health, Alaris Products / cleared 2005-10-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)