(1) CryoPatch SG Pulmonary Human Cardiac Hemi-Artery - Artery Patch, SGPH00 Cryopreserved Decellu...
FDA Recall #Z-2532-2024 — Class II — May 28, 2024
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.
Recalling Firm
Artivion, Inc — Kennesaw, GA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
2 arteries, 1 patch
Distribution
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.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated