Revaclear 400 Dialyzer recall due to potential internal blood leaks
Baxter Healthcare recalls Revaclear 400 Dialyzer units due to potential internal blood leaks caused by twisted gaskets. The defect may affect dialysis patients worldwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a life-sustaining medical device with potential for internal blood leaks. Although no illnesses or injuries have been reported, the theoretical hazard poses risk of harm to vulnerable dialysis patients.
Plain-English summary
Baxter Healthcare Corporation is recalling Revaclear 400 Dialyzer units (Product Code 114749M) due to potential for internal blood leaks caused by a twisted gasket in the dialyzer.
The affected dialyzers are used to treat chronic and acute renal failure by hemodialysis. A total of 449,544 units have been distributed to multiple countries including the United States (Guam and St. Thomas USVI), 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, and Trinidad and Tobago.
Patients and healthcare facilities using these dialyzers should contact Baxter Healthcare Corporation for information about the recall and recommended actions regarding the affected lot numbers.
The recalled product
- Product
- Revaclear 400 Dialyzer. Product Code: 114749M. Not distributed in the USA. Used to treat chronic and acute renal failure by hemodialysis.
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device — Dialyzer
- Hazard
- blood-leak
- gasket-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Not distributed in the USA. Product Code: 114749M
- Lot Numbers: C422202401
- C422202501
- C422202601
- C422202701
- C422202801
- C422202901
- C422203001
- C422203101
- C422203201
- C422203301
- C422203401
- C422203501
- C422203601
- C422203701
- C422203801
- C422203901
- C422204001
- C422204101
- C422204201
Distribution
Distributed nationwide across the United States.
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