FDAFDA · Food and drugs·Recall number Z-0762-2023
Revaclear 300 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.
Published December 28, 2022 · Recall initiated: November 23, 2022
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Baxter Healthcare Corporation
- Distributor
- 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.
- Lot
- UDI-DI: 07332414123055; Product Code: 114745L; All lot numbers from C419128801-C422128401
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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