NxStage PureFlow-B Solution. Catalog numbers: RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-406, RFP-453, RFP-454, RF
FDA device recall Z-1864-2025 · posted 2025-05-28 · Open, Classified
Recall details
- Recalling firm
- NxStage Medical Inc
- Reason for recall
- 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.
- Action taken
- NxStage notified consignees via mail on 04/28/2025. Consignees were instructed to check inventory for affected units and cease use if any are on hand, complete and return the response form, and contact NxStage Customer Service to arrange return of all affected units.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- KPO
- Quantity affected
- 115,465 cases (230,930 units)
- Distribution
- US Nationwide distribution.
- Date initiated
- 2025-04-28
- Date posted
- 2025-05-28
- Location
- Lawrence, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO: NXSTAGE PUREFLOW-B SOLUTION (K053286) | Nxstage Medical, Inc. | 2005-12-22 |