NxStage PureFlow B Solution Recalled for Potential Bag Bursting
NxStage Medical is recalling 59,100 units of PureFlow B Solution because the smaller chamber may burst, releasing electrolyte fluid that can injure eyes or skin.
What this means for you
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 involves a risk-of-harm product (potential chemical injury to eyes/skin) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
NxStage Medical, Inc. is recalling 59,100 units of NxStage PureFlow B Solution-RFP-400, a premixed dialysate for hemodialysis. The product is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate. The recall covers specific lot numbers distributed nationwide in the United States.
The recall is being issued because the smaller chamber of the two-chamber bag can burst. If the bag bursts, electrolyte fluid may be released. This fluid can cause injury if it comes into contact with the eyes or skin.
Healthcare providers and patients using this product should stop using the affected lots immediately. The source text does not specify additional consumer instructions or report any illnesses or injuries.
The recalled product
- Product
- NxStage PureFlow B Solution-RFP-400, Premixed Dialysate for Hemodialysis. 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
- 59,100
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 (20)
- Lot Numbers: F1709268
- F1709269
- F1709276
- F1709277
- F1710321
- F1711329
- F1711334
- F1711339
- F1711340
- F1711341
- F1711342
- Q1711804
- Q1711805
- Q1711806
- Q1711807
- Q1711846
- Q1711847
- Q1711848
- Q1711849
- Q1711850
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 8 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.
See all 8 products in this recall →Related recalls
Same manufacturer · NxStage Medical, Inc.
See all →- HighNxStage PureFlow-B Solution Bags Perimeter Seal Failure Risk
FDA (Devices) · 2025-06-04
- HighNxStage PureFlow-B Hemodialysis Solution Bags Recalled Due to Bursting Chambers and Caustic Fluid
FDA (Devices) · 2024-06-26
- HighNxStage Low Volume Cartridge Recalled for Hemodialysis Risk
FDA (Devices) · 2019-12-25
- ModerateNxStage PureFlow B Solution Recalled for Incorrect Product Number Labeling
FDA (Devices) · 2019-06-12
- ModerateNxStage PureFlow B Solution Recalled for Incorrect Product Number Labeling
FDA (Devices) · 2019-06-12
Same hazard · chemical injury
See all →- High