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Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 40 cc; Product Numbe...

FDA Recall #Z-1065-2013 — Class II — November 27, 2012

Recall #Z-1065-2013 Date: November 27, 2012 Classification: Class II Status: Terminated

Product Description

Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 40 cc; Product Number: IAB-05840-LWS. The IAB is utilized for intra-aortic balloon counter-pulsation therapy.

Reason for Recall

Potential to have an internal leak at the fill port of the stainless steel tip, which may necessitate removal and replacement of the catheter.

Recalling Firm

Arrow International Inc — Reading, PA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

637 units

Distribution

Worldwide Distribution -- USA, Belgium, Great Britain, Italy, Kazakhstan, Latvia, Russia, Slovenia, Turkey, and South Africa.

Code Information

Lot Numbers: KF2073694 KF2083874 KF2083966 KF2094179 KF2073788 KF2083927 KF2084059

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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