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Paragonix SherpaPak Cardiac Transport System
Paragonix Technologies Inc · Model SHRP-1001-003 · UDI-DI 00869582000330
MSB
Prescription
10
510(k) clearances
73
Adverse events (15 deaths)
2
Recalls
15
Facilities
Description
Paragonix SherpaPak Heart Connector Box Contains 4 heart connectors: 00869582000354 (10mm x 1) 00869582000361 (18mm x 1) 00869582000378 (25.4mm x 1) 00869582000385 (32mm x 1)
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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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.