FDA-Device2022-12-28Class II
Revaclear 400 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.
Baxter Healthcare Corporation
Hazard
Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak
Sold states
Worldwide distribution - US Nationwide and the countries of Canada, China, Australia, New Zealand, Austria, Egypt, France, Germany, Ireland, Italy, Morocco, Qatar, Saudi Arabia, South Africa, Spain, United Kingdom, Bahamas, Barbados, Belize, Bermuda, Colombia, Dominican Republic, Ecuador, Guatemala, Honduras, Mexico, Panama, St. Thomas, Trinidad and Tobago.
Affected count
6,338,280 units
Manufactured in
1 Baxter Pkwy, Deerfield, IL, United States
Products
Revaclear 400 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0763-2023Don't want to check this manually?
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