CryoPatch SG Pulmonary Hemi-Artery Patch
Class I - DangerousWhat Should You Do?
- Check if you have this product: Model #: SGPHOO Serial #10685466
- 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 device is recalled due to donor ineligibility of released human tissue. The firm received information that the tissue donor's blood culture tested positive for Enterobacter cloacae.
- 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 Patch
Product Codes/Lot Numbers:
Model #: SGPHOO Serial #10685466
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1219-2019
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.