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Baxter Healthcare Corporation recalls Revaclear 300 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.
Recalled December 28, 2022 · FDA recall Z-0762-2023 · Baxter Healthcare
Hazard
Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak · FDA Class II
Units
14,053,824 units
Sold at
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.
Description
Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak
Product
Revaclear 300 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.
Manufacturer(s)
Baxter Healthcare Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →