Z-0764-2023 Class II Ongoing
FDA device recall Z-0764-2023 was initiated by Baxter Healthcare Corporation on Nov 23, 2022 and is designated Class II. Reason for recall: Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak The recall status is ongoing. Affected quantity: 1,140,096 units.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 28, 2022
- Initiation Date
- Nov 23, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,140,096 units
Product Description
Revaclear 400 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
No distribution in the USA. Product Code: 114749M; All lot numbers from C422202401 C422227201
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0764-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026