The Recall Desk
HighFDA (Devices)·Z-0504-2019·Announced 2018-12-05

NxStage PureFlow B Solution Recalled for Potential Bag Burst Injury Risk

NxStage Medical is recalling 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

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 (medical device) where injury has not yet been reported, fitting the 'High' severity criteria for potential injury without confirmed cases.

Plain-English summary

NxStage Medical, Inc. is recalling 114,777 units of NxStage PureFlow B Solution-RFP-404, a premixed dialysate for hemodialysis. The product is indicated for use with renal replacement therapy systems that utilize sterile premixed dialysate during hemodialysis.

The recall was initiated 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 affected lots were distributed nationwide in the United States.

Consumers and healthcare providers should stop using the affected product immediately. The specific lot numbers subject to this recall are listed in the agency's official documentation. Users should contact the manufacturer or their healthcare provider for further instructions on how to proceed.

The recalled product

Product
NxStage PureFlow B Solution-RFP-404, 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
114,777

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: F1708230
  • F1708231
  • F1708234
  • F1708235
  • F1708237
  • F1708245
  • F1708246
  • F1708247
  • F1708250
  • F1708251
  • F1708253
  • F1708254
  • F1708256
  • F1709260
  • F1709261
  • F1709267
  • F1710327
  • F1710328
  • F1711343
  • F1711344

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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