Recall Z-2064-2016 ยท FRN Pump, Infusion
CareFusion 303, Inc.
Alaris System PC Unit Model 8015 with software versions 9.17 and 9.19; Central programming, monitoring and power supply component for the Alaris System.
| Date | May 12, 2016 |
| Status | Terminated |
| Reason | A patient weight can be populated incorrectly under certain conditions when using the RESTORE feature to restore infusions running on the Alaris LVP module model 8100 and the Alaris Syringe module model 8110. |
| Root cause | Software design |
| Action | An Urgent Medical Device Recall Letter was sent to customers on 5/31/16 to inform them that BD had identified an issue with the Alaris System PC unit model 8015 with software versions 9.17 and 9.19. Firm has received reports that a patient weight can be populated incorrectly under certain conditions when using the RESTORE feature to restore infusions running on the Alaris LVP module model 8100 and the Alaris Syringe module model 8110. The letter informs the customers of the potential risk and the required action for users. Customers are informed that BD will contact them within 60 days to in |
| Quantity | 69,693 units |
| Distribution | Distributed US (nationwide) and in 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 |