CryoValve SG Cryopreserved Pulmonary Human Heart Valve
Class I - DangerousWhat Should You Do?
- Check if you have this product: Model/Catalog Number: SGPV00; Serial ID Number: 12578856; UDI-DI Number: 00877234000447; Expiration Date 04/05/2028
- 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:
- Artivion, Inc
- Reason for Recall:
- The blood cultures performed as part of the organ donation process were positive for Staphylococcus aureus.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
CryoValve SG Cryopreserved Pulmonary Human Heart Valve
Product Codes/Lot Numbers:
Model/Catalog Number: SGPV00; Serial ID Number: 12578856; UDI-DI Number: 00877234000447; Expiration Date 04/05/2028
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1545-2024
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