NxStage PureFlow B Solution Recalled for Incorrect Product Number Labeling
NxStage Medical is recalling 1,998 units of PureFlow B Solution because certain lots were mislabeled with the incorrect product number.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text identifies the issue as a labeling error (incorrect product number) without reporting any illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
NxStage Medical, Inc. is recalling 1,998 units of NxStage PureFlow B Solution, Reference RFP-400, Model M535RFP4000. The product is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
The recall was initiated because certain lots were mislabeled with an incorrect product number. The affected lot number is Q1811792, with an expiration date of 11/1/2020.
The product was distributed nationwide in Arizona, California, the District of Columbia, Florida, Georgia, Illinois, Indiana, Michigan, North Carolina, New Hampshire, Nevada, Pennsylvania, Texas, and Virginia. Consumers and healthcare providers should stop using the affected product and contact the manufacturer for further instructions.
The recalled product
- 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.
- Manufacturer
- NxStage Medical, Inc.
- Hazard
- Affected units
- 1,998
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Number: Q1811792 Exp Date: 11/1/2020
Distribution
Part of a larger recall action
This product is one of 2 recalled by NxStage Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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