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Devices
Device Recall Premixed Dialysate for Hemodialysis
Model / Serial
RFP-400 - M535RFP4000 RFP-400-BB - 00842289101258 RFP-401 M - 535RPF4010 RFP-401-BB - 00842289101265 RFP-402 - M535RFP4020 RFP-403 - M535RFP4030 RFP-404- M535RFP4040 RFP-405 - M535RFP4050 RFP-406 - M535RFP4060 RFP-453 - M535RFP4530 RFP-454 - M535RFP4540 RFP-455 - M535RFP4550 RFP-456 - M535RFP4560
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
US nationwide distribution
Product Description
NxStage PureFlow B Solution - Premixed Dialysate for Hemodialysis with NxStage System One
Manufacturer
NxStage Medical, Inc.
1 Event
Recall of Device Recall Premixed Dialysate for Hemodialysis
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Manufacturer
NxStage Medical, Inc.
Manufacturer Address
NxStage Medical, Inc., 350 Merrimack Street, Lawrence MA 01843-1748
Manufacturer Parent Company (2017)
Nxstage Medical Inc
Source
USFDA
Language
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