Alaris PC unit model 8015. The Alaris PC unit is the central programming, monitoring and power supply component for the
FDA device recall Z-0876-2012 · posted 2012-01-26 · Terminated
Recall details
- Recalling firm
- CareFusion 303, Inc.
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- 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.
- Date initiated
- 2011-09-13
- Date posted
- 2012-01-26
- Date terminated
- 2012-01-31
- Location
- San Diego, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ALARIS SYSTEM PC UNIT, MODEL 8001 (K051641) | Cardinal Health, Alaris Products | 2005-10-20 |