Arrow International Inc recalls ARROW¿ Bipolar Electrode Catheter with shrouded pins , 6 Fr, 110 cm Product Code: AI-06210-S Product Usage: Arrow elect…

Recall date

July 30, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-3197-2018

FDA classification

Class II

Brand / firm

Arrow International Inc

Sold / distributed

US in the state of PA

Why it was recalled

Products are labeled with an incorrect expiration date

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

ARROW¿ Bipolar Electrode Catheter with shrouded pins , 6 Fr, 110 cm Product Code: AI-06210-S Product Usage: Arrow electrophysiology catheters are intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording