Recall Z-1132-2018— NxStage Medical, Inc.

Name: FDA recall Z-1132-2018
Creator: U.S. Food and Drug Administration
Published: 2017-11-10

Class II · Terminated

Class II FDA medical device recall by NxStage Medical, Inc., initiated 2017-11-10, terminated 2019-12-06. It names one FDA 510(k) clearance: K053286. Product: NxStage PureFlow B Solution - Premixed Dialysate for Hemodialysis with NxStage System One. Reason: Using different fluid formulations of NxStage PureFlow B Solution at the same time during treatment may cause patient health risk. The NxStage PureFlow B Solution is for use with systems that use one premixed dialysate during hemodialysis. The original labeling did not warn against mixing dialysate formulations and did not instruct staff to verify that the fluid is flowing during use..

Recalling firm: NxStage Medical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-11-10
Terminated: 2019-12-06
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 - Premixed Dialysate for Hemodialysis with NxStage System One

Reason for recall

Using different fluid formulations of NxStage PureFlow B Solution at the same time during treatment may cause patient health risk. The NxStage PureFlow B Solution is for use with systems that use one premixed dialysate during hemodialysis. The original labeling did not warn against mixing dialysate formulations and did not instruct staff to verify that the fluid is flowing during use.

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