NxStage PureFlow-B Solution Recalled for Potential Mislabeled Product
NxStage Medical is recalling 1,480 cases of PureFlow-B Solution due to potential mislabeling. The product is used for hemodialysis.
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 involves a potential labeling error without reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
NxStage Medical, Inc. is recalling 1,480 cases of NxStage PureFlow-B Solution, Model/Catalog Number RFP-401. The product is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis. The recall was initiated because the product may be mislabeled.
The affected product was distributed nationwide, including in Illinois, South Carolina, Texas, Virginia, Florida, Arkansas, and New York. The specific code for the recalled product is F023444.
Consumers and healthcare facilities should stop using the recalled product and contact NxStage Medical for further instructions or a replacement.
The recalled product
- 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.
- Manufacturer
- NxStage Medical, Inc.
- Hazard
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)
- F023444
Distribution
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