Recall Z-1214-2013— NxStage Medical, Inc.

Name: FDA recall Z-1214-2013
Creator: U.S. Food and Drug Administration
Published: 2013-03-18

Class II · Terminated

Class II FDA medical device recall by NxStage Medical, Inc., initiated 2013-03-18, terminated 2014-09-17. It names one FDA 510(k) clearance: K042045. Product: NxStage PureFlow-B Solution, Model/Catalog Number: RFP-401, packaged in a case The NxStage PureFLow-B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.. Reason: Product may be mislabeled..

Recalling firm: NxStage Medical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-03-18
Terminated: 2014-09-17
Firm location: Lawrence, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K042045 — NXSTAGE PUREFLOW-B SOLUTIONNxstage Medical, Inc.·cleared 2004-08-27

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, packaged in a case The NxStage PureFLow-B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.

Reason for recall

Product may be mislabeled.

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