Date Initiated by Firm | March 06, 2013 |
Date Posted | April 15, 2013 |
Recall Status1 |
Terminated 3 on May 08, 2014 |
Recall Number | Z-1112-2013 |
Recall Event ID |
64653 |
510(K)Number | K051641 |
Product Classification |
Pump, infusion - Product Code FRN
|
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 |
not available |
Recalling Firm/ Manufacturer |
Carefusion Corporation 3750 Torrey View Ct San Diego CA 92130-2622
|
Manufacturer Reason for Recall | The recall was initiated because Carefusion has identified potential risk associated with bolus programming with the Alaris PC unit (model 8015) software version 9.12. Automating infusion pump parameter input from either the electronic medical record (EMR) or the Alaris Auto-ID module for a continuous infusion with a bolus dose option may result in a loss of information from the Guardrails Data s |
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 actions 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. The letter stated that a Carefusion representatives will contact customers by telephone to schedule field remediation. For questions call Carefusion Support Center at 888-562-6018, Customer Advocacy at 888-812-3266, and/or Technical Support at 888-812-3229. |
Quantity in Commerce | 4,090 total units |
Distribution | Worldwide Distribution USA Nationwide and the countries of Australia and Canada. |
Total Product Life Cycle | TPLC Device Report |
|
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.
|
510(K) Database | 510(K)s with Product Code = FRN
|