Recall Z-1606-2016 ยท FRN Pump, Infusion
CareFusion 303, Inc.
Alaris PC unit, Model 8015 The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System.
| Date | Mar 24, 2016 |
| Status | Terminated |
| Reason | The Alaris PC units model 8015 may display a system error code 133.6080 due to failure with the super capacitor (C245) at power up on the Alaris PC unit logic boards. |
| Root cause | Nonconforming Material/Component |
| Action | The firm, Carefusion, sent a "Medical Device Recall Notification" letter dated March 30, 2016 to its customers. The letter described the product, problem, the potential risk involved and the required action for users. The customers were instructed to do the following: If you observe System Error code 133.6080, remove the PC unit from use and contact the CareFusion Support Center, and promptly complete and return the enclosed Customer Response Card. Customers with recall related questions are instructed to contact CareFusion Support Center at (888) 562-6018 from 7am-4pm PST, M-F, or by emai |
| Quantity | 23,397 units |
| Distribution | Worldwide Distribution: US (nationwide) and countries of: Australia, Great Britain 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 |