Recall Z-1707-2019— NxStage Medical, Inc.

Name: FDA recall Z-1707-2019
Creator: U.S. Food and Drug Administration
Published: 2019-04-11

Class II · Terminated

Class II FDA medical device recall by NxStage Medical, Inc., initiated 2019-04-11, terminated 2020-06-08. It names one FDA 510(k) clearance: K053286. Product: NxStage PureFlow B Solution, REF RFP-401, M535RPF4010 NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.. Reason: Certain lots were mislabeled with incorrect product number..

Recalling firm: NxStage Medical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-04-11
Terminated: 2020-06-08
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, REF RFP-401, M535RPF4010 NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.

Reason for recall

Certain lots were mislabeled with incorrect product number.

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