Recall Z-1228-2007 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
NxStage Medical, Inc.
NxStage Cartridge Express, CAR-170, for hemodialysis.
| Date | Sep 20, 2007 (initiated Jul 27, 2007) |
| Status | Terminated |
| Reason | Potential for dialysate leaks from the cartridge during treatment. |
| Root cause | Process change control |
| Action | NxStage initiated the recall by letter on 8/24/07 advising users of the specific lots to be removed from use. Prior notifications were issued on July 27, 2007, July 30, 2007 and July 31, 2007 notifying users of the potential for leaks and instructions to detect leaks prior to use. |
| Quantity | 12,085 cases |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |