Medtronic Custom Pack EVNP Clinical with AP40 1/B (PERFUSION M448036B 1/B) ...



Medtronic Custom Pack EVNP Clinical with AP40 1/B (PERFUSION M448036B 1/B). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood during extracorporeal circulation. Cardiotomy blood is collected, filtered, and defoamed before mixing with the venous blood, which is filtered. The primary blood-contacting surfaces of the CVR are coated with Balance Biosurface to reduce platelet activation and adhesion and preserve platelet function. (Generic Name: Cardiopulmonary bypass oxygenator).
Components:
Recall Date:    Feb 4, 2021
Mfg:
Medtronic Perfusion Systems
Mfg Country:
United States
Recall ID:    87271
Product ID:    185837
Enforcement Date:    Mar 24, 2021
Last Published:    Apr 1, 2021

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Emert Number:    Z-1194-2021
Emert Status:    Updated