Z-0762-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- December 28, 2022
- Initiation Date
- November 23, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14,053,824 units
Product Description
Revaclear 300 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.
Reason for Recall
Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak
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.
Code Information
UDI-DI: 07332414123055; Product Code: 114745L; All lot numbers from C419128801-C422128401