Recall Z-0826-2012 ยท FKR Subsystem, Proportioning
NxStage Medical, Inc.
NXStage PureFlow SL SAK-303 - 2 dialysate sacks (SAK) with concentrate for use with PureFlow SL, Rx The NxStage PureFLow SL is an optional accessory to the NxStage System One that prepares dialysate for use during hemodialysis, as prescribed by the physician.
| Date | Jan 20, 2012 (initiated Dec 14, 2011) |
| Status | Terminated |
| Reason | Report of high conductivity failure alarms with the PureFlow SL due to excess concentrate by weight in the product (SAK) dialysate Preparation System |
| Root cause | Employee error |
| Action | On December 13, 2011, NxStage sent replacement product for overnight delivery and initiated phone contact with all consignees of the product . In addition, NxStage sent an "IMPORTANT MEDICAL DEVICE RECALL" notice dated December 14, 2011 to its consignees/customers. The notice describes the product, problem and actions to be taken. The customers were instructed to use SAKs from a different lot or premixed dialysate bags (RFPs), until their replacement SAKs arrived; set aside all SAKs from listed lot number; record their inventory; dispose of the SAKs following their normal practices, and comple |
| Quantity | 1,192 devices |
| Distribution | Nationwide distribution. |
| FDA record | Open on fda.gov |