Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0501-2019 — 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.

U.S. FDA — Device Enforcement · United States · 2018-10-17 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0501-2019
Date of alert: 2018-10-17
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: NxStage Medical, Inc.
Product category: device
Product type: Devices

Reported risk: PureFlow B Solution smaller chamber of the two chamber bag can burst electrolyte fluid and cause injury if it comes in contact with the eyes or skin

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Recall Z-0501-2019 — 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.

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