Baxter Healthcare Corporation 2022-12-28 Health serious FDA
Health · FDA · Recall #FDA-Z-0762-2023
Revaclear 300 dialyzers. Indicated for treatment of chronic and acute renal failure… Recall
Issued December 28, 2022 · Baxter Healthcare Corporation
In December 2022, Baxter Healthcare Corporation recalled the Revaclear 300 dialyzers. Indicated for treatment of chronic and acute renal failure…, a serious health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak
What you should do
- 1 Stop using Revaclear 300 dialyzers. Indicated for treatment of chronic and acute renal failure… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Baxter Healthcare Corporation to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Baxter Healthcare Corporation
- Category
- Health
- Recall date
- December 28, 2022
- Units affected
- Not reported
- Sold at
- Worldwide distribution - US Nationwide and the countries of Canada, China, Australia, New Zealand, Austria, Egypt, France, Germany, Ireland,
- Recall number
- FDA-Z-0762-2023
- Made in
- United States
- Issuing agency
- FDA
In context
- Baxter Healthcare Corporation has 36 recalls in our database, including 5 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 870th Health recall we've logged in 2022.