Devices

Polyflux Revaclear Max, Capillary Dialyzer

Model / Serial
Lot Numbers: C413204601, C413204801, C413204901, C413205101, C413205201, C413205301, C413205401, C413205501, C413205601, C413205701, C413205801, C413205901, C413206001, C414200101, C414200201, C414200301, C414200401, C414200701, C414200801, C414200901, C414201301, C414201401, C414201501, and C414201601.
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution -- USA, including the territory of Puerto Rico, and the countries of Bermuda and Australia.
Product Description
Polyflux Revaclear Max, Capillary Dialyzer, Model Number 110634; || Gambro Renal Products, Inc. || Intended for the treatment of acute and chronic renal failure by hemodialysis.
Manufacturer
Gambro Renal Products, Incorporated
1 Event
- Recall of Polyflux Revaclear Max, Capillary Dialyzer

Manufacturer

Gambro Renal Products, Incorporated

Manufacturer Address
Gambro Renal Products, Incorporated, 14143 Denver West Pkwy, Lakewood CO 80401-3266
Manufacturer Parent Company (2017)
Baxter International
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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