The Recall Desk
HighFDA (Devices)·Z-0501-2019·Announced 2018-12-05

NxStage PureFlow B Solution Recalled Due to Bag Burst Risk

NxStage Medical is recalling PureFlow B Solution because the smaller chamber of the two-chamber bag can burst, releasing electrolyte fluid that may 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 (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 approximately 186,476 units of NxStage PureFlow B Solution-RFP-401, 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. If the bag bursts, electrolyte fluid may be released and cause injury if it comes into contact with the eyes or skin. The affected lots were distributed nationwide in the United States.

Healthcare facilities and consumers should stop using the affected lots immediately and contact NxStage Medical for instructions on how to return the product. The specific lot numbers affected are listed in the structured product information provided by the FDA.

The recalled product

Product
NxStage PureFlow B Solution-RFP-401, 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
186,476

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: F1708229
  • F1709262
  • F1709263
  • F1709264
  • F1709265
  • F1709266
  • F1709273
  • F1709274
  • F1709275
  • F1709278
  • F1709279
  • F1709280
  • F1709281
  • F1709282
  • F1709283
  • F1709284
  • F1709286
  • F1709287
  • Q1709423
  • Q1709428

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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