Recall Z-0006-2011 ยท FRN Pump, Infusion
CareFusion Corporation
CareFusion Alaris PC Unit Model 8015 (formerly Medley PC Unit): Alaris PC Units (Model 8015) with logic board part number TC10005522 manufactured and serviced between December 20, 2008 and May 6, 2009; and Alaris PC Units (with logic board part number TC10005572 manufactured and serviced between May 7, 2009 and September 8, 2009. For use with Alaris infusion and monitoring systems.
| Date | Oct 13, 2010 (initiated Jul 13, 2010) |
| Status | Terminated |
| Reason | Under certain wireless network conditions a communication error can occur, which freezes the PC Unit screen, which may result in a delay of therapy. A delay of therapy may result in serious injury and/or death. CareFusion identified this potential risk associated with the Alaris PC unit model 8015 only (PC Unit) manufactured between December-2008 and September-2009. |
| Root cause | Component design/selection |
| Action | CareFusion sent the customer notification letter to all customers using the affected Alaris PC Unit beginning August 24, 2010. The customer notification letter is 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, self-addressed 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 the issue and the required actions for u |
| Quantity | 17,081 units (17,050 in US) |
| Distribution | Nationwide and worldwide to: Canada, Netherlands, New Zealand and Singapore |
| 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 |