FDA Device

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

Hazard

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.

What You Should Do

Remedy

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.

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Products

Alaris PC unit model 8015. The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System.
Brand
CareFusion 303, Inc.
UPC
The affected units have unique serial numbers for traceability.

Units Affected

1039 units

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