NxStage Medical recalls

2 official recalls and safety alerts involving NxStage Medical since 2024-06, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.

This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with NxStage Medical or the relevant agency.

1. 2025-06-04
2. US
   Drugs & medicalClass II

   NxStage Medical Inc recalls NxStage PureFlow-B Solution. Catalog numbers: RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-406, RFP-453, RFP-454, RFP-456.

   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…

   FDA · DeviceNxStage Medical IncUS Nationwide distribution.Official notice →
3. 2024-06-26
4. US
   Drugs & medicalClass II

   NxStage Medical Inc recalls NxStage PureFlow-B Solution, Premixed Dialysate for Hemodialysis, Device Catalog Numbers RFP-400, RFP-401, RFP-402, RFP-403, RFP-404,…

   The smaller chamber of the two chamber bag is bursting when nurses are attempting to mix the two chambers prior to use. The electrolyte fluid in the small chamber of the NxStage PureFlow B Solution has a pH of less…

   FDA · DeviceNxStage Medical IncUS Nationwide distribution.Official notice →