Cryovalve(R) SG Pulmonary Human Heart Valve, Catalog Number SGPVVOO
Class I - DangerousWhat Should You Do?
- Check if you have this product: Serial Number 10988203
- 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:
- CryoLife, Inc.
- Reason for Recall:
- Devices, which met FDA and AATB eligibility criteria, were distributed. Final autopsy and toxicology reports indicated the presence of morphine in the urine.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Cryovalve(R) SG Pulmonary Human Heart Valve, Catalog Number SGPVVOO
Product Codes/Lot Numbers:
Serial Number 10988203
Distribution:
Distributed in: AR, OH
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2271-2018
Related Recalls
Product is not approved for use in the EU and should not have been distributed in the EU.
On November 10, 2020, it was discovered that there are post- processing microbial culture test failures for other allografts, processed using a TRIS saline solution lot that was also used in processing allografts subjected to the recall.
On November 10, 2020, it was discovered that there are post- processing microbial culture test failures for other allografts, processed using a TRIS saline solution lot that was also used in processing allografts subjected to the recall.