Z-1706-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 12, 2019
- Initiation Date
- April 11, 2019
- Termination Date
- June 8, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1998 units
Product Description
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 Pattern
US Nationwide Distribution - AZ, CA, DC, FL, GA, IL, IN, MI, NC, NH, NV, PA, TX & VA
Code Information
Lot Number: Q1811792 Exp Date: 11/1/2020