Recall Z-1069-04 ยท KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
NxStage Medical, Inc.
NxStage Cartridge Express. A disposable extracorporeal blood and fluid pathway and a hemo filter. Model #CAR-124, 6 units per case.
| Date | Jul 20, 2004 (initiated Apr 14, 2004) |
| Status | Terminated |
| Reason | Pinhole leaks on the replacement (RF) side FMP bag in certain lots of its disposable cartridge balance chambers resulting in loss of dialysate or ultrafiltrate |
| Root cause | Other |
| Action | Voluntary recall notice dated 4/14/04 sent UPS, overnight with signature required to both ICU/CCU (Acute accounts) and Chronic accounts. Firm to remove and replace product that contains a disposable component from a new supplier that has demonstrated to be less reliable resulting in pinhole leaks. |
| Quantity | 234 units |
| Distribution | CA, IL, IN, MD, IA, MO, NJ, OH, VT |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040696 | MODIFICATION TO NXSTAGE SYSTEM ONE Nxstage Medical, Inc., May 26, 2004 |