Artivion, Inc recalls (1) CryoPatch SG Pulmonary Human Cardiac Hemi-Artery - Artery Patch, SGPH00 Cryopreserved Decellularized Cardiac Tissue Allograft Prepared…
Grafts were found to have been approved, released, shipped and implanted with an invalid test results.
Read the official notice →- Date
- 2024-08-14
- Country
- United States
- Brand
- Artivion
- Product
- (1) CryoPatch SG Pulmonary Human Cardiac Hemi-Artery - Artery Patch, SGPH00 Cryopreserved Decellularized Cardiac Tissue Allograft Prepared…
- Classification
- Class II
- Units
- US Nationwide distribution in the states of CA, DC, FL, and NY.
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Artivion recalls
- 2024-04-24
USArtivion, Inc recalls CryoValve SG Cryopreserved Pulmonary Human Heart Valve
The blood cultures performed as part of the organ donation process were positive for Staphylococcus aureus.
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