Alaris PC unit model 8015 recallZ-0876-2012 · CareFusion 303, Inc. · initiated Sep 13, 2011
Terminated All recalls posted in January 2012
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
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.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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.
Recall details
- Recall number
- Z-0876-2012
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Sep 13, 2011
- Posted by the FDA
- Jan 26, 2012
- Recalling firm
- CareFusion 303, Inc.
- Quantity
- 1039 units
- Product code
- FRN
- FDA submissions
- K051641
- 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 description
Alaris PC unit model 8015. The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System.
Code information (models, lots, serial numbers)
The affected units have unique serial numbers for traceability.
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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