Recall Z-1239-2016 ยท FRO Dressing, Wound, Drug
CareFusion 303, Inc.
Alaris PC Unit, Infusion Pump Model 8000, Part No. TC10005092
| Date | Mar 24, 2016 (initiated Feb 12, 2016) |
| Status | Terminated |
| Reason | CareFusion is recalling the Alaris PC unit because a component on the PC unit power supply may cause a "System Error" or "Missing Battery" error code (120.4630). |
| Root cause | Under Investigation by firm |
| Action | A customer notification letter dated 2/25/16 will be sent to all their customers who purchased the Alaris PC unit (Model 8000) to inform them that CareFusion is recalling it because a component on the PC unit power supply board may cause a "System Error" or "Missing Battery" error code (120.4630). The letter informs the customers of the potential risk involved and the actions to be taken. Customers with recall related questions are instructed to call CareFusion Support Center at (888) 562-6018, 7am-4pm PST, Mon-Fri or email at supportcenter@carefusion.com. Customers with clinical inquires, |
| Quantity | 170 units |
| Distribution | Nationwide in US: AR, AZ, CA, FL, GA, IN, KY, MD, MI, MN, MO, NJ, NM, NY, OH, OR, PA, SC, TN, TX, VA, WI. |
| 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 |