Recall Z-1545-05 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Gambro Renal Products
Prisma continuous renal replacement system.
| Date | Oct 1, 2005 (initiated Aug 16, 2005) |
| Status | Terminated |
| Reason | Critically ill patients undergoing continuous renal replacement therapy may suffer excessive fluid loss. |
| Root cause | Software design |
| Action | Consignees were notified by press release and letter on 8/16/2005. |
| Quantity | 1964 units |
| Distribution | Nationwide, including Puerto Rico and Washington, DC. Military consignees in CA and TX. VA consignees in AZ, CA, DC, FL, GA, MO, OH, OR, PA, PR, TX, UT, VA and WI. No foreign distribution by US firm. |
| FDA record | Open on fda.gov |