Revaclear 400 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.
Reported: December 28, 2022 Initiated: November 23, 2022 #Z-0763-2023
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
Details
- Recalling Firm
- Baxter Healthcare Corporation
- Units Affected
- 6,338,280 units
- Distribution
- 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.
- Location
- Deerfield, IL
Frequently Asked Questions
What product was recalled? ▼
Revaclear 400 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.. Recalled by Baxter Healthcare Corporation. Units affected: 6,338,280 units.
Why was this product recalled? ▼
Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 28, 2022. Severity: Moderate. Recall number: Z-0763-2023.
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