NxStage PureFlow B Solution Recalled for Missing Labeling Warnings
NxStage Medical is recalling 1,243,400 units of PureFlow B Solution because the original labeling failed to warn against mixing dialysate formulations.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of harm to patients due to missing safety warnings, but the source text does not report specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
NxStage Medical, Inc. is recalling 1,243,400 units of NxStage PureFlow B Solution - Premixed Dialysate for Hemodialysis with NxStage System One. The product was distributed nationwide in the United States.
The recall was initiated because the original labeling did not warn against using different fluid formulations of the solution at the same time during treatment. Additionally, the labeling did not instruct staff to verify that the fluid is flowing during use. Using different formulations simultaneously may cause patient health risk.
Healthcare facilities and users should stop using the affected units and contact NxStage Medical for further instructions. The affected product codes are listed in the official recall documentation.
The recalled product
- Product
- NxStage PureFlow B Solution - Premixed Dialysate for Hemodialysis with NxStage System One
- Manufacturer
- NxStage Medical, Inc.
- Affected units
- 1,243,400
Distribution
Distributed nationwide across the United States.
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