Recall Z-1860-2014 ยท FKR Subsystem, Proportioning
NxStage Medical, Inc.
NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow SL REF: SAK-307 Lactate 40, Potassium 1, Sodium 140, Calcium 3, Magnesium 1, Chloride 105, Glucose (mg/dL) 100 Batch Size (liters) 50 The SAK is one of the disposables used with NxStage PureFlow SL Dialysate Preparation System. The SAK is a disposable bag pre-filled with dialysate concentrate that is then filled with purified wa
| Date | Jun 24, 2014 (initiated May 14, 2014) |
| Status | Terminated |
| Reason | SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification |
| Root cause | Material/Component Contamination |
| Action | NxStage issued Initial recall letter dated 5/14/14 to dialysis centers. An error was noted and an updated letter dated 5/15/14 was resent to dialysis centers. The updated 5/15/14 letter was emailed to all current active PureFlow SL patients who had provided an email address followed by UPS next business day letter sent to all current active PureFlow SL patients. Accounts are requested to examine inventory and remove product. Contact NxStage Customer Service to arrange for return of all affected product and for replacement product to be sent. If you have any questions or comments, please feel |
| Quantity | 8683 cases |
| Distribution | Worldwide Distribution - USA (nationwide) and Internationally to France, Netherlands, Spain, Sweden, and the UK. |
| FDA record | Open on fda.gov |