Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
GAMBRO Capillary Dialyzer Recalled by Baxter Healthcare Corp. Due to Potential presence of particulate matter on the blood...
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 Baxter Healthcare Corp. directly.
Affected Products
GAMBRO Capillary Dialyzer, Polyflux(R) Revaclear MAX, STERILE, Product code 110634 Product Usage: The Revaclear Max dialyzer is a single use device used for treatment of chronic and acute renal failure by hemodialysis.
Quantity: 22,656 units
Why Was This Recalled?
Potential presence of particulate matter on the blood side of the dialyzer
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Baxter Healthcare Corp.
Baxter Healthcare Corp. has 126 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report