Baxter Coseal Premix, Surgical Sealant, Product Codes: a) 934070; b) 934071; c) 934072
Class I - DangerousWhat Should You Do?
- Check if you have this product: All serial numbers a) Product code 934070, UDI/DI 5413765404610; b) Product code 934071, UDI/DI 5413765404627; c) Product code 934072, have no UDI/DI.
- 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:
- Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for Use (IFU) or Prescribing Information (PI).
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Baxter Coseal Premix, Surgical Sealant, Product Codes: a) 934070; b) 934071; c) 934072
Product Codes/Lot Numbers:
All serial numbers a) Product code 934070, UDI/DI 5413765404610; b) Product code 934071, UDI/DI 5413765404627; c) Product code 934072, have no UDI/DI.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0657-2024
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