Recall Z-0504-2019— NxStage Medical, Inc.

Name: FDA recall Z-0504-2019
Creator: U.S. Food and Drug Administration
Published: 2018-10-17

Class II · Terminated

Class II FDA medical device recall by NxStage Medical, Inc., initiated 2018-10-17, terminated 2020-08-26. It names one FDA 510(k) clearance: K053286. Product: NxStage PureFlow B Solution-RFP-404, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.. Reason: PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin.

Recalling firm: NxStage Medical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-10-17
Terminated: 2020-08-26
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-RFP-404, Premixed Dialysate for Hemodialysis NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.

Reason for recall

PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin

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