Gambro Renal Products Inc 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. Recall
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Gambro Renal Products Inc
Lot Codes / Batch Numbers
Lot No. C412120501 to C412127501, C413100101 to C413129601, C414100101 to Lots C414119301 and Lot C414120001
Products Sold
Lot No. C412120501 to C412127501, C413100101 to C413129601, C414100101 to Lots C414119301 and Lot C414120001
Gambro Renal Products Inc is recalling Polyflux Revaclear Dialyzer, Model Number 110633. The Polyflux Revaclear¿ and Polyflux Revaclear¿ due to Gambro is initiating a field action for Polyflux Revaclear Dialyzer and Polyflux Revaclear Max Dialyzer due to potential tears in the individual packa. This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 13, 2026