NxStage PureFlow B Solution Recalled for Potential Bag Bursting and Injury
NxStage Medical is recalling specific lots of PureFlow B Solution because the smaller chamber of the two-chamber bag can burst, releasing electrolyte fluid that may cause injury if it contacts eyes or skin.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states that the fluid can 'cause injury' if it contacts eyes or skin. Per the rubric, a Class II recall with injury reports or significant injury risk is classified as Severe (Score 4).
Plain-English summary
NxStage Medical, Inc. is recalling 21,071 units of NxStage PureFlow B Solution-RFP-402, a premixed dialysate indicated for use with renal replacement therapy systems during hemodialysis. The recall affects specific lot numbers: F1708255, F1709285, F1710323, Q1711861, Q1711863, Q1712021, Q1712022, Q1712023, Q1712033, Q1801345, Q1802399, and Q1802400. The product was distributed nationwide in the United States.
The recall is being issued because the smaller chamber of the two-chamber bag can burst, releasing electrolyte fluid. This fluid can cause injury if it comes into contact with the eyes or skin. The U.S. Food and Drug Administration has classified this as a Class II recall, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
Healthcare facilities and consumers should stop using the affected lots immediately. Users should check the lot numbers on their product packaging against the list provided in this notice. If the lot number matches, the product should be returned to the supplier or NxStage Medical, Inc. for replacement or refund.
The recalled product
- Product
- NxStage PureFlow B Solution-RFP-402, 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.
- Affected units
- 21,071
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 (12)
- Lot Numbers: F1708255
- F1709285
- F1710323
- Q1711861
- Q1711863
- Q1712021
- Q1712022
- Q1712023
- Q1712033
- Q1801345
- Q1802399
- Q1802400
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.
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