The Recall Desk
SevereFDA (Devices)·Z-0507-2019·Announced 2018-12-05

NxStage PureFlow B Solution Recalled for Potential Bag Bursting Hazard

NxStage Medical is recalling PureFlow B Solution because the smaller chamber of the 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 agency classified this as a Class II recall, and the source text explicitly states that the bursting bag can cause injury to eyes or skin, meeting the criteria for a Severe rating due to significant injury potential.

Plain-English summary

NxStage Medical, Inc. is recalling 15,880 units of NxStage PureFlow B Solution-RFP-RFP-456, a premixed dialysate indicated for use with renal replacement therapy systems during hemodialysis. The recall covers specific lot numbers: F1708258, F1710322, Q1711910, Q1711911, Q1712093, Q1801227, Q1801342, Q1801343, Q1802393, and Q1803816. The product was distributed nationwide in the United States.

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.

Healthcare providers and patients should stop using the affected lots of NxStage PureFlow B Solution immediately. Users should check their inventory for the listed lot numbers and contact NxStage Medical for instructions on how to return or dispose of the product.

The recalled product

Product
NxStage PureFlow B Solution-RFP-RFP-456, 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
15,880

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 (10)

  • Lot Numbers: F1708258
  • F1710322
  • Q1711910
  • Q1711911
  • Q1712093
  • Q1801227
  • Q1801342
  • Q1801343
  • Q1802393
  • Q1803816

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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