[pending] NxStage PureFlow-B Solution. Catalog numbers: RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-406,
Pending LLM rewrite. Source: FDA_DEVICE Z-1864-2025.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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.
The recalled product
- Product
- NxStage PureFlow-B Solution. Catalog numbers: RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-406, RFP-453, RFP-454, RFP-456.
- Manufacturer
- NxStage Medical Inc
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Q2407308
- Q2407147
- Q2407148
- Q2407149
- Q2407313
- Q2407386
- Q2407387
- Q2407388
- Q2407389
- Q2407063
- Q2407064
- Q2407065
- Q2407067
- Q2407068
- Q2407069
- Q2407070
- Q2407071
- Q2407217
- Q2407218
- Q2407219
Distribution
Distributed nationwide across the United States.
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