Recall Z-1073-2014— NxStage Medical, Inc.

Name: FDA recall Z-1073-2014
Creator: U.S. Food and Drug Administration
Published: 2014-01-24

Class II · Terminated

Class II FDA medical device recall by NxStage Medical, Inc., initiated 2014-01-24, terminated 2014-08-29. It names one FDA 510(k) clearance: K053286. Product: NxStage PureFlow-B Solution; Model/Catalog Number: RFP-401. Product is packaged in a case containing two individual 5L bags. The NxStage PureFlow-B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.. Reason: Mislabeled product..

Recalling firm: NxStage Medical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-01-24
Terminated: 2014-08-29
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; Model/Catalog Number: RFP-401. Product is packaged in a case containing two individual 5L bags. The NxStage PureFlow-B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.

Reason for recall

Mislabeled product.

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