Recall Z-1811-2015 ยท FRN Pump, Infusion
CareFusion 303, Inc.
Alaris PC unit model 8015, Infusion pump. software version 9.17 Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. The software is embedded in the Alaris PC unit.
| Date | Jun 16, 2015 (initiated May 13, 2015) |
| Status | Terminated |
| Reason | An issue with the cancel functionality used during atypical infusion programming to cancel user inputted values. An infusion may start that is greater than or less than the hospital established limits for the specific medication. |
| Root cause | Software design |
| Action | CareFusion sent an Urgent Medical Device Recall Notification letter dated May 13, 2015 to customers. The letter identified the affected product, problem and the recommended actions to be taken. Customers are informed that CareFusion has released a software upgrade to address this issue. CareFusion will contact all affected customers within 60 days to initiate the scheduling process for the software upgrade installation. Customers with recall related questions are instructed to contact CareFusion Support Center at (888) 562-6018, 7am-4pm PT, supportcenter@carefusion.com. Customers with ad |
| Quantity | 63 units |
| Distribution | US Nationwide Distribution |
| 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 |