Recall Z-0492-2011 ยท FRN Pump, Infusion
CareFusion Corporation
Alaris PC unit Model 8000 only when used with Alaris Pump module or Alaris Syringe module
| Date | Aug 2, 2010 |
| Status | Terminated |
| Reason | Than recall was initiated because CareFusion has identified identified a potential risk associated with the Alaris PC unit formerly known as Medley PC unit (PC Unit) model 8000 only when used with Alaris Pump module (Pump module) or Alaris Syringe module' (Syringe module), This recall notification details the potential risk and recommended steps for users to take if they encounter a specific PC |
| Root cause | Device Design |
| Action | CareFusion will send by registered return receipt mail the customer notification letter to all customers using the affected Alaris PC Unit beginning August 24, 2010. The customer notification letter will be addressed to the Directors of Nursing, Risk Management, and Biomedical Engineering. Customers will be required to confirm receipt of the notification by returning the Recall Response Card to CareFusion by postage-paid, selfaddressed mail, fax or email. The recall notice informed the customers of the reason for the notice, the units affected, the potential risk, a step-by-step description of |
| Quantity | 94,146 units |
| Distribution | Nationwide in the United States, Canada, Mexico, and the European Union |
| 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 |