Recall Z-0335-2016— NxStage Medical, Inc.

Name: FDA recall Z-0335-2016
Creator: U.S. Food and Drug Administration
Published: 2015-10-29

Class II · Terminated

Class II FDA medical device recall by NxStage Medical, Inc., initiated 2015-10-29, terminated 2019-11-19. It names one FDA 510(k) clearance: K122051. Product: NxStage System One S Cycler - Model no. NX1000-3. For home hemodialysis.. Reason: Ultrafiltration Volume (UFV) may not decrease during treatment-software error. The UF pump may continue to run and remove fluid even after the target UF volume has been removed.

Recalling firm: NxStage Medical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-10-29
Terminated: 2019-11-19
Firm location: Lawrence, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K122051 — NXSTAGE SYSTEM ONENxstage Medical, Inc.·cleared 2013-04-23

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 System One S Cycler - Model no. NX1000-3. For home hemodialysis.

Reason for recall

Ultrafiltration Volume (UFV) may not decrease during treatment-software error. The UF pump may continue to run and remove fluid even after the target UF volume has been removed

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