(1) CryoPatch SG Pulmonary Human Cardiac Hemi-Artery - Artery Patch, SGPH00 Cryopreserved Decellularized Cardiac Tissue Allograft Prepared with SynerGraft (SG) Technology; and (2) CryoPatch SG Pulmonary Human Cardiac Branch Patch, SGP020, Cryopreserved Decellularized Cardiac Tissue Allograft Prepared with SynerGraft (SG) Technology.
Class I - DangerousWhat Should You Do?
- Check if you have this product: (1) SGPH00 - Serial #12071128, exp. 17Nov2027; and serial #11586249, exp. 04May2025; UDI-DI: 00877234000461. (2) SGP020 - Serial #12658767, exp. 15Aug2028; UDI-DI: 00877234000485.
- 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:
- Grafts were found to have been approved, released, shipped and implanted with an invalid test results.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
(1) CryoPatch SG Pulmonary Human Cardiac Hemi-Artery - Artery Patch, SGPH00 Cryopreserved Decellularized Cardiac Tissue Allograft Prepared with SynerGraft (SG) Technology; and (2) CryoPatch SG Pulmonary Human Cardiac Branch Patch, SGP020, Cryopreserved Decellularized Cardiac Tissue Allograft Prepared with SynerGraft (SG) Technology.
Product Codes/Lot Numbers:
(1) SGPH00 - Serial #12071128, exp. 17Nov2027; and serial #11586249, exp. 04May2025; UDI-DI: 00877234000461. (2) SGP020 - Serial #12658767, exp. 15Aug2028; UDI-DI: 00877234000485.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2532-2024
Related Recalls
Grafts were found to have been approved, released, shipped and implanted with an invalid test results.
The blood cultures performed as part of the organ donation process were positive for Staphylococcus aureus.