Recall Z-1112-2013 ยท FRN Pump, Infusion
Carefusion Corporation
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
| Date | Apr 15, 2013 (initiated Mar 6, 2013) |
| Status | Terminated |
| Reason | 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 |
| Root cause | 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 Sup |
| Quantity | 4,090 total units |
| Distribution | Worldwide Distribution USA Nationwide and the countries of Australia and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051641 | ALARIS SYSTEM PC UNIT, MODEL 8001 Cardinal Health, Alaris Products, Oct 20, 2005 |