NxStage PureFlow-B Solution Recalled for Mislabeled Product
NxStage Medical is recalling 969 cases of PureFlow-B Solution due to mislabeling. The product is used in hemodialysis systems.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 labeling error without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
NxStage Medical, Inc. is voluntarily recalling 969 cases of NxStage PureFlow-B Solution, Model/Catalog Number RFP-401. Each case contains two individual 5-liter bags of solution. 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 was mislabeled. The affected lot number is F113662. The recall was initiated on January 24, 2014, and was terminated on August 29, 2014.
The product was distributed in the United States, including the states of New York, Texas, Idaho, Arkansas, California, and Alabama. The FDA classified this recall as Class II, which means there is a reasonable probability that the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
The recalled product
- Product
- NxStage PureFlow-B Solution; Model/Catalog Number: RFP-401. Product is packaged in a case containing two individual 5L bags. The NxStage PureFlow-B Solution is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during…
- 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)
- Lot Number: F113662
Distribution
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