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Open, Classified

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

FDA Recall Z-1864-2025 · Posted 2025-05-28

Recalling FirmNxStage Medical Inc
Recall StatusOpen, Classified
Product CodeKPO
Date Initiated2025-04-28
Product Quantity115,465 cases (230,930 units)

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.

Firm Action

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

Distribution Pattern

US Nationwide distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K053286MODIFICATION TO: NXSTAGE PUREFLOW-B SOLUTIONNxstage Medical, Inc. · 2005-12-22

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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