FDA-Device2015-03-11Class II
ARROW FiberOptix Intra-Aortic Balloon Catheter Kit, 40 cc 7.5 Fr Product Code: IAB-05840-LWS The Arrow IAB is utilized for intra-aortic balloon counter-pulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle
Arrow International Inc
Hazard
Outer package product label incorrectly identifies the product as FiberOptix Flex IAB 7.5Fr rather than the correct FiberOptix IAB 8Fr
Sold states
Worldwide Distribution - USA (nationwide) and Internationally to Belgium
Affected count
165 units
Manufactured in
2400 Bernville Road, N/A, Reading, PA, United States
Products
ARROW FiberOptix Intra-Aortic Balloon Catheter Kit, 40 cc 7.5 Fr Product Code: IAB-05840-LWS The Arrow IAB is utilized for intra-aortic balloon counter-pulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1233-2015Don't want to check this manually?
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