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Medtronic Perfusion Systems recalls The Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda Bioactive Surface is a single-use, microporou
Recalled December 17, 2014 · FDA recall Z-0531-2015 · Medtronic Perfusion Systems
Hazard
Medtronic initiated an Urgent Medical Device Recall for 66 distributed Affinity FusionTM Oxygenation Systems with Carmeda Bioactive Surface due to damaged heat exchangers. Product affected by this issue is limited to model CB841 sold stand alone or incorporated in Total Systems TS1614R1 and TS1595R7. UPDATED: Recall was updated to incorporate three additional lots affected. · FDA Class II
Units
66, UPDATE: 168 additional devices.
Sold at
US Distribution to states of: CA and FL. UPDATED: OUS: Czech Republic and Switzerland.
Description
Medtronic initiated an Urgent Medical Device Recall for 66 distributed Affinity FusionTM Oxygenation Systems with Carmeda Bioactive Surface due to damaged heat exchangers. Product affected by this issue is limited to model CB841 sold stand alone or incorporated in Total Systems TS1614R1 and TS1595R7. UPDATED: Recall was updated to incorporate three additional lots affected.
Product
The Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda Bioactive Surface is a single-use, microporous, hollow-fiber, gas-exchange device with plasma resistant fiber and integrated heat exchanger and arterial filter. The oxygenator is bonded on its primary blood contacting surfaces with a non-leaching biocompatible surface to reduce platelet activation and adhesion and preserve platelet function. The device is non-toxic, nonpyrogenic, and supplied sterile in individual packaging.
Manufacturer(s)
Medtronic Perfusion Systems
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →