NxStage PureFlow B Solution recall: Labeling Error
NxStage PureFlow B Solution, REF RFP-401, M535RPF4010 NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that…
Why was NxStage PureFlow B Solution recalled?
Certain lots were mislabeled with incorrect product number.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Number: Q1811789 & Q1811790 Exp Date: 11/1/2020
- Product
- NxStage PureFlow B Solution, REF RFP-401, M535RPF4010 NxStage PureFlow B Solution is indicated for use with renal replacement therapy systems that…
- Recalling firm
- NxStage Medical, Inc.
- Quantity
- 3,940 units
- Distribution
- US Nationwide Distribution - AZ, CA, DC, FL, GA, IL, IN, MI, NC, NH, NV, PA, TX & VA
- Recall date
- June 12, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)