The Recall Desk
SevereFDA (Devices)·Z-0505-2019·Announced 2018-12-05

NxStage PureFlow B Solution Recalled for Potential Bag Bursting

NxStage Medical is recalling PureFlow B Solution because the bag's smaller chamber may burst, releasing electrolyte fluid that can injure 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 agency classification is FDA Class II, and the source text explicitly states that the fluid can cause injury to eyes or skin, meeting the criteria for a Severe rating.

Plain-English summary

NxStage Medical, Inc. is recalling 16,585 units of NxStage PureFlow B Solution-RFP-406, a premixed dialysate for hemodialysis. The product is distributed nationwide in the United States. The recall involves specific lot numbers: F1710314, Q1712034, Q1801223, Q1801224, Q1801344, Q1802451, Q1803684, Q1803817, and Q1804904.

The recall was initiated because the smaller chamber of the two-chamber bag can burst. If this occurs, electrolyte fluid may be released and cause injury if it comes into contact with the eyes or skin. The product is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.

Healthcare providers and patients using this product should stop using the affected lots immediately. Users should contact NxStage Medical, Inc. for further instructions on how to return or dispose of the product. The FDA has classified this recall as Class II, indicating a reasonable probability that the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
NxStage PureFlow B Solution-RFP-406, 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.
Category
Medical Device — Dialysis Solution
Hazard
Affected units
16,585

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 (9)

  • Lot Numbers: F1710314
  • Q1712034
  • Q1801223
  • Q1801224
  • Q1801344
  • Q1802451
  • Q1803684
  • Q1803817
  • Q1804904

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 →

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