Recall Z-0200-2007 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Gambro Renal Products, Inc.
Gambro Phoenix Hemodialysis Machine, Model numbers: 6022933700, 6023006700, 6022966700, Gambro Dasco S.p.A., Italy.
| Date | Nov 21, 2006 (initiated May 12, 2006) |
| Status | Terminated |
| Reason | Defective Heat Exchanger/membrane; this may result in perforation of the membrane thus allowing the presence of infectious organisms and/or pathogens to pass from patient to patient. |
| Root cause | Nonconforming Material/Component |
| Action | Consignees were notified by fax on 05/12/2006 and by letter on 05/16/2006. Until it was determined that their Phoenix system did not have an affected heat exchanger, users were instructed to disinfect the hydraulics flow path after each patient treatment. Gambro personnel will inspect each system and replace any affected heat exchangers. |
| Quantity | 613 machines (US), 170 machines (foreign) |
| Distribution | Worldwide Distribution, USA, including VA facilities in GA and NC. Foreign distribution to Canada, Korea and Mexico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K001156 | PHOENIX HEMODIALYSIS DELIVERY SYSTEM, GAMBRO CARTRIDGE FOR HEMODIALYSIS BLOOD TUBING SET Gambro Renal Products, Jul 7, 2000 |