FDA-Device2022-12-28Class II
Revaclear 400 Dialyzer. Product Code: 114749M. Not distributed in the USA. Used to treat chronic and acute renal failure by hemodialysis.
Baxter Healthcare Corporation
Hazard
Potential for Internal Blood Leaks due to a twisted gasket in the dialyzer
Sold states
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.
Affected count
449,544 units
Manufactured in
1 Baxter Pkwy, Deerfield, IL, United States
Products
Revaclear 400 Dialyzer. Product Code: 114749M. Not distributed in the USA. Used to treat chronic and acute renal failure by hemodialysis.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0761-2023Don't want to check this manually?
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