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Terminated

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

FDA Recall Z-0876-2012 · Posted 2012-01-26

Recalling FirmCareFusion 303, Inc.
Recall StatusTerminated
Product CodeFRN
Date Initiated2011-09-13
Date Terminated2012-01-31
Product Quantity1039 units

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.

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K051641ALARIS SYSTEM PC UNIT, MODEL 8001Cardinal Health, Alaris Products · 2005-10-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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