NxStage PureFlow B Solution Recalled for Incorrect Product Number Labeling
NxStage Medical is recalling specific lots of PureFlow B Solution because they 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 labeling error.
Plain-English summary
NxStage Medical, Inc. is recalling 3,940 units of NxStage PureFlow B Solution, Reference RFP-401, Model M535RPF4010. The recall involves Lot Numbers Q1811789 and Q1811790, which have an expiration date of 11/1/2020. This product is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.
The reason for the recall is that certain lots were mislabeled with an incorrect product number. The affected units were 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 facilities should check their inventory for these specific lot numbers and product references. If the product is found, it should be removed from use and returned to the supplier or NxStage Medical, Inc. according to their instructions.
The recalled product
- Product
- NxStage PureFlow B Solution, REF RFP-401, M535RPF4010 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
- 3,940
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: Q1811789 & Q1811790 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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