Recall Z-0811-2018 ยท FKR Subsystem, Proportioning
NxStage Medical, Inc.
NxStage Dialysate Sack: 1) REF SAK-301 UDI-M535SAK3010, 2) REF SAK-302 UDI-M535SAK3020, 3) REF SAK-303 UDI-M535SAK3030, 4) REF SAK-304 UDI-M535SAK3040, 5) REF SAK-306 UDI-M535SAK3060, 6) REF SAK-307 UDI- M535SAK3070, 6) REF SAK-402 UDI-M535SAK4020, 7) REF SAK-405 UDI- M535SAK4050, 8) REF SAK-406 UDI-M535SAK4060 & REF SAK-407 UDI- M535SAK4070 Hemodialysis systems and accessories
| Date | Jan 29, 2018 |
| Status | Terminated |
| Reason | May contain endotoxin levels which have been confirmed to exceed the ANSI/AAMI quality standard dialysis fluid of 0.5 EU/ml when used to prepare product. |
| Root cause | Material/Component Contamination |
| Action | On January 29, 2018 Product Recall Notices & Recall Reply Forms included were emailed to those patients for whom the firm had an email address. Hard copy letters were sent via UPS second day air to patients for whom NxStage did not have an email address. All Dialysis centers were contacted via email. In addition to the active patients and dialysis center consignees of affected product, recall letters were also emailed to the Dialysis Center Home Training Nurse Manager for all active or dropped patients who were shipped affected product, and corporate contacts for national dialysis accounts. |
| Quantity | 16,039 cases/2 units |
| Distribution | Worldwide Distribution - USA (nationwide) and to the countries of : United Kingdom & Spain |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K140571 | NXSTAGE PUREFLOW SL Nxstage Medical, Inc., May 15, 2014 |