Recall Z-0032-2007 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Gambro Renal Products, Inc.
Gambro Prismaflex Hemodialysis Machine, Catalogue Number 6023014700, Gambro Dasco S.p.A, Italy.
| Date | Oct 12, 2006 (initiated May 16, 2006) |
| Status | Terminated |
| Reason | A potential risk of infusing air or infusion fluid to the patient during dialysis. Also, a possibility of an incorrect scale reading of the amount of patient fluid removal. |
| Root cause | Software design |
| Action | Consignees were notified by letter on 05/16/2006. |
| Quantity | 153 units (US) |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041005 | GAMBRO PRISMAFLEX AND GAMBRO PRISMAFLEX M60 & M100 SETS Gambro Renal Products, Oct 7, 2004 |