Artivion, Inc: (1) CryoPatch SG Pulmonary Human Cardiac Hemi-Artery - Artery Patch, SGPH00 Cryopreserved Decellularized Cardiac Tissue Allograft Prepared with SynerGraft (SG) Technology; and (2) CryoP

Hazard

Grafts were found to have been approved, released, shipped and implanted with an invalid test results.

Details from the source

Reason for recall: Grafts were found to have been approved, released, shipped and implanted with an invalid test results. Distribution: US Nationwide distribution in the states of CA, DC, FL, and NY. Quantity: 2 arteries, 1 patch Lot/code info: (1) SGPH00 - Serial #12071128, exp. 17Nov2027; and serial #11586249, exp. 04May2025; UDI-DI: 00877234000461. (2) SGP020 - Serial #12658767, exp. 15Aug2028; UDI-DI: 00877234000485.

UPC codes

00877234000461, 00877234000485

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.