Z-2532-2024 Class II Ongoing
FDA device recall Z-2532-2024 was initiated by Artivion, Inc on May 28, 2024 and is designated Class II. Reason for recall: Grafts were found to have been approved, released, shipped and implanted with an invalid test results. The recall status is ongoing. Affected quantity: 2 arteries, 1 patch.
Recall Details
- Product Type
- Devices
- Report Date
- August 14, 2024
- Initiation Date
- May 28, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2 arteries, 1 patch
Product Description
(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.
Reason for Recall
Grafts were found to have been approved, released, shipped and implanted with an invalid test results.
Distribution Pattern
US Nationwide distribution in the states of CA, DC, FL, and NY.
Code Information
(1) SGPH00 - Serial #12071128, exp. 17Nov2027; and serial #11586249, exp. 04May2025; UDI-DI: 00877234000461. (2) SGP020 - Serial #12658767, exp. 15Aug2028; UDI-DI: 00877234000485.