FDA recall Z-1132-2018

Product

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.

Distribution

US nationwide distribution

Key facts

Status

Terminated

Initiation date

2017-11-10

Report date

2018-03-28

Termination date

2019-12-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lawrence, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1132-2018