Date Initiated by Firm | March 06, 2013 |
Date Posted | April 15, 2013 |
Recall Status1 |
Terminated 3 on September 02, 2014 |
Recall Number | Z-1098-2013 |
Recall Event ID |
64728 |
510(K)Number | K051641 |
Product Classification |
Pump, infusion - Product Code FRN
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Product | Alaris PC unit model 8015 with software version 9.12
Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. |
Code Information |
unit model 8015 with software version 9.12 |
Recalling Firm/ Manufacturer |
Carefusion Corporation 3750 Torrey View Ct San Diego CA 92130-2622
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Manufacturer Reason for Recall | The recall was initiated because Carefusion has received reports of a communication error on the Alaris PC unit model 8015 with software version 9.12 when the Alaris EtCO2 module or Alaris SpO2 module is attached. |
FDA Determined Cause 2 | Software design |
Action | CareFusion sent an Urgent Medical Device Recall Notification letter dated March 6, 2013 to all affected customers. The letter identified the affected product, problem and action to be taken. Customers are required to confirm receipt of the notification by returning the Recall Response card to Carefusion by postage-paid, self-addressed mail, fax, or email. Carefusion representatives will contact customers by telephone to schedule field remediation. For questions contact CareFusion Support Center at 888-562-6018, Customer Advocacy at 888-812-3266 and/or Technical Support at 888-812-3229. |
Quantity in Commerce | 9,241 units |
Distribution | Worldwide Distribution - USA (nationwide) and the countries of Australia and China. |
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
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