Recall Z-1311-2015 ยท FRN Pump, Infusion
CareFusion 303, Inc.
Alaris PC units, Model No. 8015. Infusion pump.
| Date | Mar 23, 2015 (initiated Mar 12, 2015) |
| Status | Terminated |
| Reason | CareFusion is recalling the Alaris PC unit because of an error code. The error code may occur upon power on during the "Power-On Self Test" due to a keypad issue. |
| Root cause | Process control |
| Action | CareFusion sent an Urgent: Medical Device Recall Notification letter dated March 12, 2015, to all affected customers. The letter informs the customers that CareFusion has received service reports of a system error on the Alaris PC unit 8015. The letter informs customers of the problems identified and the actions to be taken. Customers with recall related questions are instructed to contact CareFusion Support Center at (888) 562-6018, supportcenter@carefusion.com. Customers with adverse event reports are instructed to contact customer advocacy at (888) 812-3266, customerfeedback@carefusio |
| Quantity | 56,015 units |
| Distribution | Worldwide Distribution - USA (nationwide), Canada, European Union, Singapore and Australia. |
| 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 |