Revaclear 400 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.

Reason: Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak

Code information: No distribution in the USA. Product Code: 114749M; All lot numbers from C422202401 C422227201

Distribution pattern: 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.