NxStage PureFlow-B Solution recall: Labeling Error
NxStage PureFlow-B Solution, Model/Catalog Number: RFP-401, packaged in a case The NxStage PureFLow-B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
Why was NxStage PureFlow-B Solution recalled?
Product may be mislabeled.
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?
F023444
- Product
- NxStage PureFlow-B Solution, Model/Catalog Number: RFP-401, packaged in a case The NxStage PureFLow-B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
- Recalling firm
- NxStage Medical, Inc.
- Quantity
- 1480 cases (2 bags per case)
- Distribution
- Nationwide Distribution including IL, SC, TX, VA, FL, AR, and NY.
- Recall date
- May 8, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)