Recall Z-2532-2024
Artivion, Inc · initiated May 28, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
(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.
Codes / lots: (1) SGPH00 - Serial #12071128, exp. 17Nov2027; and serial #11586249, exp. 04May2025; UDI-DI: 00877234000461. (2) SGP020 - Serial #12658767, exp. 15Aug2028; UDI-DI: 00877234000485.
Reason for recall
Grafts were found to have been approved, released, shipped and implanted with an invalid test results.
FDA-determined cause: Under Investigation by firm
Action taken
The recalling firm issued letters to their Field Representatives on 5/24/2024 or 5/28/2024 for distribution to the consignees via email or hand delivery. The first date consignees were notified was on 5/28/2024 by their Field Representative. The letter provided the details on the tissue the consignee received, the date it was implanted, and the implanting surgeon. The issue was described and it was pointed out there was no indication the impacted tissues were contaminated and unlikely to pose a health risk to the patient. The letter discussed the testing conducted on each allograft and that the identified allograft was reported to have an invalid Post-Processing Sterility test result or a Pre-Processing Culture test result (depending on the consignee letter), which represents a technical failure in the test, not an indication of a positive result. A response form was enclosed for return to acknowledge receipt of the notification.
Details
- Recall number
- Z-2532-2024
- Initiated
- May 28, 2024
- Posted by FDA
- August 8, 2024
- Product code
- DXZ – Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
- Quantity
- 2 arteries, 1 patch
- Distribution
- US Nationwide distribution in the states of CA, DC, FL, and NY.
- Recalling firm
- Artivion, Inc, Kennesaw, GA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2531-2024 Class II | CryoValve SG Pulmonary Human Heart Valve, SGPV00, Cryopreserved Decellularized Heart…Grafts were found to have been approved, released, shipped and implanted with an invalid test results. | 05/28/2024Open, Classified |