NxStage recalls PureFlow-B Solution with catalog numbers RFP-400 to RFP-456 due to potential perimeter seal failure causing electrolyte fluid splash to user's face during mixing. Affected units include specific lot numbers.
Potential for the perimeter seal on the small chamber of the two-chamber bag to fail causing the electrolyte fluid to splash into the face of the user when attempting to open the peel seam to mix the two chambers prior to treatment.
NxStage is recalling PureFlow-B Solution devices with catalog numbers RFP-400 through RFP-456 because the perimeter seal on the small chamber might fail, causing electrolyte fluid to splash into the user's face when mixing the solution. This could lead to eye or face irritation if the seal breaks during use.
The perimeter seal on the small chamber of the two-chamber bag may fail during the process of opening the peel seam to mix the solution. If this happens, electrolyte fluid could splash into the user's face, potentially causing eye or face irritation.
Patients using NxStage PureFlow-B Solution for dialysis treatment are most at risk. The affected units include specific catalog numbers and lot numbers listed in the recall notice.
Check the device catalog number on the product (RFP-400 to RFP-456) and the lot number (e.g., Q2407307). The UDI-DI number starts with M535RFP followed by the catalog number and lot number.
Identify the catalog number (RFP-400 to RFP-456) and lot number (e.g., Q2407307) on the product.
Reach out to NxStage Medical Inc for further assistance or to confirm if your device is affected.
The perimeter seal on the small chamber of the two-chamber bag may fail during the process of opening the peel seam to mix the solution, causing electrolyte fluid to splash into the user's face.
Catalog numbers RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-406, RFP-453, RFP-454, and RFP-456 are affected.
Check the device catalog number (RFP-400 to RFP-456) and lot number (e.g., Q2407307) on the product. The UDI-DI number starts with M535RFP followed by the catalog number and lot number.
We’ve drafted a message you can send NxStage to request your refund or repair — edit it as you like.
Subject: Recall Z-1864-2025 — NxStage NxStage Hello, I own a NxStage that is covered by recall Z-1864-2025 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.
