Revaclear 400 dialyzers. Indicated for treatment of recall
Revaclear 400 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.
Why was Revaclear 400 dialyzers. Indicated for treatment of recalled?
Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
a. UDI-DI: 07332414124076; Product Code: 114746L; All lot numbers from C421221401-C422228501. b. UDI-DI: 07332414126209; Product Code: 114746M; All lot numbers from C422218601-C422219901
- Product
- Revaclear 400 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 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.
- Recall date
- December 28, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)