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Subsystem, Proportioning

FDA product code FKR · Class 2 · Gastroenterology, Urology

46
Registered devices
20
Adverse events
10
Recalls
12
510(k) clearances

Devices with this code

Dialysate Sack (SAK) with Concentrate — NXSTAGE MEDICAL, INC.Dialysate Sack (SAK) with Concentrate — NXSTAGE MEDICAL, INC.PUREFLOW SL — NXSTAGE MEDICAL, INC.PUREFLOW SL — NXSTAGE MEDICAL, INC.Dialysate Sack (SAK) with Concentrate — NXSTAGE MEDICAL, INC.Dialysate Sack (SAK) with Concentrate — NXSTAGE MEDICAL, INC.Dialysate Sack (SAK) with Concentrate — NXSTAGE MEDICAL, INC.Dialysate Sack (SAK) with Concentrate — NXSTAGE MEDICAL, INC.PUREFLOW SL — NXSTAGE MEDICAL, INC.Dialysate Sack (SAK) with Concentrate — NXSTAGE MEDICAL, INC.PUREFLOW SL — NXSTAGE MEDICAL, INC.Dialysate Sack (SAK) with Concentrate — NXSTAGE MEDICAL, INC.PUREFLOW SL — NXSTAGE MEDICAL, INC.Dialysate Sack (SAK) with Concentrate — NXSTAGE MEDICAL, INC.PUREFLOW SL PAK — NXSTAGE MEDICAL, INC.PUREFLOW SL — NXSTAGE MEDICAL, INC.Dialysate Sack (SAK) with Concentrate — NXSTAGE MEDICAL, INC.Dialysate Sack (SAK) with Concentrate — NXSTAGE MEDICAL, INC.Dialysate Sack (SAK) with Concentrate — NXSTAGE MEDICAL, INC.PUREFLOW SL — NXSTAGE MEDICAL, INC.Dialysate Sack (SAK) with Concentrate — NXSTAGE MEDICAL, INC.Dialysate Sack (SAK) with Concentrate — NXSTAGE MEDICAL, INC.Dialysate Sack (SAK) with Concentrate — NXSTAGE MEDICAL, INC.Dialysate Sack (SAK) with Concentrate — NXSTAGE MEDICAL, INC.

Recent recalls

DateFirmReason
2018-01-29NxStage Medical, Inc.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.
2014-05-14NxStage Medical, Inc.SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification
2014-05-14NxStage Medical, Inc.SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification
2014-05-14NxStage Medical, Inc.SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification
2014-05-14NxStage Medical, Inc.SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification
2014-05-14NxStage Medical, Inc.SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification
2014-05-14NxStage Medical, Inc.SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification
2014-05-14NxStage Medical, Inc.SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification
2014-05-14NxStage Medical, Inc.SAK Dialysate Concentrate contain aluminum levels which exceed internal product specification
2011-12-14NxStage Medical, Inc.Report of high conductivity failure alarms with the PureFlow SL due to excess concentrate by weight in the product (SAK) dialysate Preparation System

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.