Revaclear 400 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- 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:
- Reports of Polyurethane Displacement in the dialyzer, and might be identified as a blood leak
- 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 dialyzers. Indicated for treatment of chronic and acute renal failure by hemodialysis.
Product Codes/Lot Numbers:
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
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0763-2023
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