NxStage PureFlow B Solution-RFP-401 for hemodialysis may burst, causing injury if electrolyte fluid contacts skin or eyes. Affected lots listed. Stop using immediately.
PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin
NxStage PureFlow B Solution-RFP-401, a premixed dialysate for hemodialysis, is being recalled because its smaller chamber can burst, potentially causing injury if electrolyte fluid contacts skin or eyes. This risk affects patients using the product for kidney treatment.
The smaller chamber in the two-chamber bag can burst under normal use conditions. If this happens, electrolyte fluid may splash onto skin or eyes, causing injury. This is a serious risk during dialysis treatments.
Patients using NxStage PureFlow B Solution-RFP-401 for hemodialysis are most at risk. The product is used by individuals with kidney failure requiring regular dialysis treatments.
Check the lot number on the bag. Affected lots include F1708229 through Q1804905 as listed in the recall notice. The product is used for hemodialysis treatments.
Discontinue use of NxStage PureFlow B Solution-RFP-401 immediately if you have the affected lot numbers listed in the recall.
The smaller chamber in the two-chamber bag can burst, potentially causing injury if electrolyte fluid contacts skin or eyes.
Affected lot numbers include F1708229, F1709262 through Q1804905 as listed in the recall notice.
The recall record does not mention any remedy or replacement options.
We’ve drafted a message you can send NxStage to request your refund or repair — edit it as you like.
Subject: Recall Z-0501-2019 — NxStage NxStage Hello, I own a NxStage that is covered by recall Z-0501-2019 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.
