Recall Z-1520-2017 ยท FRN Pump, Infusion
CareFusion 303, Inc.
Alaris System PC unit, model no. 8000 and 8015. The central programming, monitoring and power supply component for the Alaris infusion pump System.
| Date | Nov 1, 2016 |
| Status | Terminated |
| Reason | Reports where the Low Battery alarm and/or the Very Low Battery alarm are not being triggered before the battery is discharged and all infusion channels are stopped. |
| Root cause | Use error |
| Action | A customer letter dated 11/1/2016 will be sent to all customers to inform them that BD has identified an issue with the Alaris System PC unit. The letter informs the customers that BD has received reports for the Alaris PC units where the Low Battery alarm and/or the Very Low Battery alarm are not being triggered before the battery is discharged and all infusion channels are stopped. The letter informs the customers of the issue and recommended steps to take. Customers with recall related questions are instructed to contact BD Support Center at (888) 562-6018, 7-4pm PT, M-F, supportcenter@ca |
| Quantity | 613,800 total units (575,221 units in US) |
| Distribution | Worldwide distribution. US nationwide, Europe, Australia, New Zealand, South Africa, Greater Asia, Middle East, 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 |