Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Polyflux Revaclear Max Recalled by Gambro Renal Products, Incorporated Due to The firm received several complaints for internal 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 Gambro Renal Products, Incorporated directly.
Affected Products
Polyflux Revaclear Max, Capillary Dialyzer, Model Number 110634; Gambro Renal Products, Inc. Intended for the treatment of acute and chronic renal failure by hemodialysis.
Quantity: 2,461,824 units total
Why Was This Recalled?
The firm received several complaints for internal blood leaks involving various lot numbers produced in late 2013.
Where Was This Sold?
Worldwide Distribution -- USA, including the territory of Puerto Rico, and the countries of Bermuda and Australia.
About Gambro Renal Products, Incorporated
Gambro Renal Products, Incorporated has 18 total recalls tracked by RecallDetector.
Related Recalls
EndoVive Safety PEG Kit Recalled by Boston Scientific Corporation Due to Recall of kits which utilized ChloraPrep Triple Swabsticks...
Boston Scientific Corporation · February 10, 2026
Owner's Booklets and Instructions for Use that are used with Recalled by Trividia Health, Inc. Due to The system labeling (user manual and online labeling)...
Trividia Health, Inc. · February 6, 2026
Artelon FlexBand Dynamic Matrix Ref: 31057 Recalled by International Life Sciences Due to Augmentation devices failed bacterial endotoxin testing.
International Life Sciences · February 6, 2026
Owner's Booklets and Instructions for Use that are used with Recalled by Trividia Health, Inc. Due to The system labeling (user manual and online labeling)...
Trividia Health, Inc. · February 6, 2026
Owner's Booklets and Instructions for Use that are used with Recalled by Trividia Health, Inc. Due to The system labeling (user manual and online labeling)...
Trividia Health, Inc. · February 6, 2026
Data sourced from the FDA (Device). Last updated March 26, 2026. View original report