Recall Z-1864-2025— NxStage Medical Inc

Name: FDA recall Z-1864-2025
Creator: U.S. Food and Drug Administration
Published: 2025-04-28

Class II · Ongoing

Class II FDA medical device recall by NxStage Medical Inc, initiated 2025-04-28. It names one FDA 510(k) clearance: K053286. 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.. Reason: 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..

Recalling firm: NxStage Medical Inc
Classification: Class II
Status: Ongoing
Initiated: 2025-04-28
Firm location: Lawrence, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K053286 — MODIFICATION TO: NXSTAGE PUREFLOW-B SOLUTIONNxstage Medical, Inc.·cleared 2005-12-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.