The Recall Desk
HighFDA (Devices)·Z-2160-2024·Announced 2024-06-26

NxStage PureFlow-B Hemodialysis Solution Bags Recalled Due to Bursting Chambers and Caustic Fluid

NxStage PureFlow-B hemodialysis solution bags may burst during preparation, releasing caustic electrolyte fluid that can cause chemical burns. Affected units are distributed nationwide.

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: This is an FDA Class II medical device recall involving a documented mechanical failure (bursting chambers) and a caustic hazard (pH < 2.0 electrolyte fluid). Although no illnesses or injuries have been reported, the product poses a clear risk of chemical burn and slip/fall injury upon contact with skin, eyes, or spillage.

Plain-English summary

NxStage PureFlow-B Solution is a premixed dialysate (electrolyte solution) for hemodialysis used in kidney dialysis treatment. The FDA recall affects 1,316,936 units with catalog numbers RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-405, RFP-406, RFP-453, RFP-454, and RFP-456, distributed nationwide.

Healthcare workers have reported that the smaller chamber in the two-chamber bags bursts when attempting to mix the chambers before use. The electrolyte fluid in the smaller chamber has a pH below 2.0, making it caustic and potentially harmful. If the chamber ruptures, the caustic fluid can contact skin or eyes, causing chemical burns. Spilled fluid also poses a slip and fall hazard.

This recall affects dialysis centers, hospitals, and other healthcare facilities nationwide that use this product.

The recalled product

Product
NxStage PureFlow-B Solution, Premixed Dialysate for Hemodialysis, Device Catalog Numbers RFP-400, RFP-401, RFP-402, RFP-403, RFP-404, RFP-405, RFP-406, RFP-453, RFP-454, RFP-456
Manufacturer
NxStage Medical Inc
Category
Medical Device — Hemodialysis Dialysate
Hazard
  • chemical-burn-risk
  • caustic-fluid
  • container-failure
  • slip-fall-risk

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)

  • Catalog Number: RFP-400
  • Primary Device Identifier: M535RFP4000
  • Catalog Number: RFP-401
  • Primary Device Identifier: M535RFP4010
  • Catalog Number: RFP-402
  • Primary Device Identifier: M535RFP4020
  • Catalog Number: RFP-403
  • Primary Device Identifier: M535RFP4030
  • Catalog Number: RFP-404
  • Primary Device Identifier: M535RFP4040
  • Catalog Number: RFP-405
  • Primary Device Identifier: M535RFP4050
  • Catalog Number: RFP-406
  • Primary Device Identifier: M535RFP4060
  • Catalog Number: RFP-453
  • Primary Device Identifier: M535RFP4530
  • Catalog Number: RFP-454
  • Primary Device Identifier: M535RFP4540
  • Catalog Number: RFP-456
  • Primary Device Identifier: M535RFP4560

Distribution

Distributed nationwide across the United States.

Related recalls

Same category