Reported Mar 11, 2015 · Terminated
ARROW FiberOptix Intra-Aortic Balloon Catheter Kit, 40 cc 7.5 Fr Product Code: IAB-05840-LWS The Arrow IAB is utilized…
Arrow International Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Arrow International Inc · 2400 Bernville Road · Reading, PA · 19605
Is this the product you have?
- ARROW FiberOptix Intra-Aortic Balloon Catheter Kit, 40 cc 7.5
- Fr Product CodeIAB-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
- Lot codes and dates
- Lot Number18F14M0001
- Amount recalled
- 165 units
Where it was sold
- Nationwide
Why it was recalled
Outer package product label incorrectly identifies the product as FiberOptix Flex IAB 7.5Fr rather than the correct FiberOptix IAB 8Fr
This product could cause temporary or reversible health problems — stop using it.
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