Medtronic Custom Pack CP 1/4-1/4 Pediatric Set 1/B (PERFUSION M484901D 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).
Recall Date: Feb 4, 2021
Mfg:
Medtronic Perfusion Systems
Mfg Country:
United States
Recall ID: 87271
Product ID: 185847
Enforcement Date: Mar 24, 2021
Last Published: Apr 1, 2021
__________
Emert Number: Z-1198-2021
Emert Status: Updated