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Class 2 Device Recall Alaris PC unit |
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Date Initiated by Firm |
September 13, 2011 |
Date Posted |
January 26, 2012 |
Recall Status1 |
Terminated 3 on January 31, 2012 |
Recall Number |
Z-0876-2012 |
Recall Event ID |
60904 |
510(K)Number |
K051641
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Product Classification |
Pump, infusion - Product Code FRN
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Product |
Alaris PC unit model 8015.
The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. |
Code Information |
The affected units have unique serial numbers for traceability. |
Recalling Firm/ Manufacturer |
CareFusion 303, Inc. 10020 Pacific Mesa Blvd San Diego CA 92121-4386
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For Additional Information Contact |
858-617-4000
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Manufacturer 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.
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FDA Determined Cause 2 |
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. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database |
510(K)s with Product Code = FRN and Original Applicant = CARDINAL HEALTH, ALARIS PRODUCTS
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