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Baxter Healthcare Corporation recalls Revaclear 400 Dialyzer. Product Code: 114746L. Used to treat chronic and acute renal failure by hemodialysis.
Recalled December 28, 2022 · FDA recall Z-0760-2023 · Baxter Healthcare
Hazard
Potential for Internal Blood Leaks due to a twisted gasket in the dialyzer · FDA Class II
Units
3,610,944 units
Sold at
Worldwide distribution. US Nationwide including Guam and St. Thomas USVI; 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, and Trinidad and Tobago.
Description
Potential for Internal Blood Leaks due to a twisted gasket in the dialyzer
Product
Revaclear 400 Dialyzer. Product Code: 114746L. Used to treat 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 →