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Recall Observatory FDA recall evidence

Device product

NxStage PureFlow B Solution - Premixed Dialysate for Hemodialysis with NxStage System One

Z-1132-2018

November 10, 2017

Class II

Product summary

Firm
NxStage Medical, Inc.
Event
Event 79276
Status
Terminated
Classification
Class II
Quantity
1243400 units
Official record key
device-enforcement:Z-1132-2018

Official wording

Reason: Using different fluid formulations of NxStage PureFlow B Solution at the same time during treatment may cause patient health risk. The NxStage PureFlow B Solution is for use with systems that use one premixed dialysate during hemodialysis. The original labeling did not warn against mixing dialysate formulations and did not instruct staff to verify that the fluid is flowing during use.

Code information: 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

Distribution pattern: US nationwide distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Using different fluid formulations of NxStage PureFlow B Solution at the same time during treatment may cause patient health risk. The NxStage PureFlow B Solution is for use with systems that use one premixed dialysate during hemodialysis. The original labeling did not warn against mixing dialysate formulations and did not instruct staff to verify that the fluid is flowing during use.