Recall Z-2076-2012 ยท FRN Pump, Infusion
CareFusion 303, Inc.
Alaris PC unit model 8015 Product Usage: The device is labeled for prescription use only.
| Date | Jul 26, 2012 (initiated May 25, 2012) |
| Status | Terminated |
| Reason | The recall was initiated because the Alaris PC unit model 8015 has a component on the PC unit power supply board that is causing an error code(120.4630) "System Error" or "Missing Battery Error" at start up. The error code is accompanied by both an audible alarm and visual error messages on the PC unit screen. |
| Root cause | Component design/selection |
| Action | Carefusion sent an Urgent: Medical Device Recall Notification letter dated June 27, 2012 to all their customers who purchased the Alaris PC unit (model 8015). The letter identified the affected units, explanation of the problem, potential risk and actions to be taken. Customers were instructed to not return their devices. If customers observe either of the error messages identified in the letter, then they were instructed to remove the PC unit from use and contact the Carefusion Support Center. Carefusion will contact their facility by phone within 60 days of receiving this notification t |
| Quantity | 112,912 units total (106,888 units in US) |
| 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 |