Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Polyflux Revaclear Dialyzer Recalled by Gambro Renal Products Inc Due to Gambro is initiating a field action for Polyflux...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Gambro Renal Products Inc directly.
Affected Products
Polyflux Revaclear Dialyzer, Model Number 110633. The Polyflux Revaclear¿ and Polyflux Revaclear¿ Max Dialyzers are single use devices intended for the treatment of acute and chronic renal failure by hemodialysis.
Quantity: 20 million dialyzers
Why Was This Recalled?
Gambro is initiating a field action for Polyflux Revaclear Dialyzer and Polyflux Revaclear Max Dialyzer due to potential tears in the individual packaging that may compromise the sterile barrier.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Gambro Renal Products Inc
Gambro Renal Products Inc has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report