Revaclear 400 Dialyzer. Product Code: 114749M. Not distributed in the USA. Used to treat chronic and acute renal failure by hemodialysis.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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, C422204301, C422204401, C422204501, C422204701.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Baxter Healthcare Corporation
- Reason for Recall:
- Potential for Internal Blood Leaks due to a twisted gasket in the dialyzer
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Revaclear 400 Dialyzer. Product Code: 114749M. Not distributed in the USA. Used to treat chronic and acute renal failure by hemodialysis.
Product Codes/Lot Numbers:
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, C422204301, C422204401, C422204501, C422204701.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0761-2023
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