CryoPatch SG Pulmonary Hemi-Artery, 1 graft
Class I - DangerousWhat Should You Do?
- Check if you have this product: Model Number SGPH00, Serial Number 10978889, Lot Number 144125, Expiration Date 05/16/2022
- 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:
- The conduit length and branch length of a SG Pulmonary Hemi-Artery were switched on the product labeling. The graft labeling indicates the conduit length is 1.0cm and the branch length is 4.5cm.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
CryoPatch SG Pulmonary Hemi-Artery, 1 graft
Product Codes/Lot Numbers:
Model Number SGPH00, Serial Number 10978889, Lot Number 144125, Expiration Date 05/16/2022
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0121-2019
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.