FDA recall Z-1706-2019

Product

NxStage PureFlow B Solution, REF RFP-400, M535RFP4000 Product 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.

Distribution

US Nationwide Distribution - AZ, CA, DC, FL, GA, IL, IN, MI, NC, NH, NV, PA, TX & VA

Key facts

Status

Terminated

Initiation date

2019-04-11

Report date

2019-06-12

Termination date

2020-06-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lawrence, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1706-2019