NxStage recalls premixed dialysate for hemodialysis due to risk of health issues if different fluid formulations are used simultaneously during treatment. The original labeling did not warn against mixing dialysate formulations.
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.
NxStage is recalling its PureFlow B Solution for hemodialysis because using different fluid formulations at the same time during treatment may cause health risks. This recall happens because the original product labeling did not warn against mixing dialysate formulations or instruct staff to check fluid flow during use.
The hazard occurs when different fluid formulations of NxStage PureFlow B Solution are used together during hemodialysis treatment. This can cause health risks because the original labeling did not warn against mixing dialysate formulations or instruct staff to verify fluid flow during use.
Hemodialysis patients and healthcare providers using NxStage PureFlow B Solution with the NxStage System One. Patients at highest risk if staff mix different dialysate formulations during treatment.
Check for the following model numbers: RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-405, RFP-406, RFP-453, RFP-454, RFP-455, RFP-456. These products were sold with the NxStage System One for hemodialysis.
Check that only one premixed dialysate formulation is used during hemodialysis treatment to avoid mixing different fluids.
The recall is because using different fluid formulations of NxStage PureFlow B Solution at the same time during treatment may cause health risks. The original labeling did not warn against mixing dialysate formulations or instruct staff to verify fluid flow during use.
Affected model numbers include RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-405, RFP-406, RFP-453, RFP-454, RFP-455, and RFP-456.
No, but you should verify that only one premixed dialysate formulation is used during treatment to avoid mixing different fluids.
We’ve drafted a message you can send NxStage to request your refund or repair — edit it as you like.
Subject: Recall Z-1132-2018 — NxStage NxStage Hello, I own a NxStage that is covered by recall Z-1132-2018 from NxStage. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
