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System And Accessories, Isolated Heart, Transport And Preservation
FDA product code MSB · Class 2 · Gastroenterology, Urology
21
Registered devices
73
Adverse events
2
Recalls
13
510(k) clearances
Devices with this code
Custodiol(R) — Dr. Franz Köhler Chemie GmbHParagonix SherpaPak Cardiac Transport System — Paragonix Technologies IncParagonix SherpaPak Cardiac Transport System — Paragonix Technologies IncParagonix SherpaPak Cardiac Transport System — Paragonix Technologies IncOCS Lung Donor Flush Set — TRANSMEDICS, INC.Servator H — GLOBAL TRANSPLANT SOLUTIONS, INC.SherpaPak Cardiac Transport System (CTS) — Paragonix Technologies IncParagonix SherpaPak Cardiac Transport System — Paragonix Technologies IncParagonix SherpaPak Cardiac Transport System — Paragonix Technologies IncCustodiol — Dr. Franz Köhler Chemie GmbHCELSIOR Cold Storage Solution — INSTITUT GEORGES LOPEZCustodiol(R) — Dr. Franz Köhler Chemie GmbHCustodiol — Dr. Franz Köhler Chemie GmbHParagonix SherpaPak Cardiac Transport System — Paragonix Technologies IncCustodiol — Dr. Franz Köhler Chemie GmbHOCS Lung System — TRANSMEDICS, INC.Custodiol(R) — Dr. Franz Köhler Chemie GmbHCustodiol(R) — Dr. Franz Köhler Chemie GmbHCustodiol(R) — Dr. Franz Köhler Chemie GmbHParagonix SherpaPak Cardiac Transport System — Paragonix Technologies IncParagonix SherpaPak Cardiac Transport System — Paragonix Technologies Inc
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-03-13 | INSTITUT GEORGES LOPEZ | The potential for risk of microbiological contamination of products due to inability to ensure sterility assurance throughout aseptic manufacturing. |
| 2011-05-12 | Vitrolife, Inc. | Precipitation observed in some bottles of Tham buffer used for adjusting pH of Perfadex prior to perfusion of donor lungs. |
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