Arrow International Inc recalls Arrow Temporary Pacing Catheter/Introducer Kit 6Fr. pacing catheter 7Fr. introducer Product Code: AI-06210-IK - Product

Recalled July 21, 2021 · FDA recall Z-2069-2021 · Arrow International

Hazard

Marketed without a 510K · FDA Class II

Units

5 units

Sold at

US Nationwide distribution in the states of FL, ID, IL, NY, OH, TX.

Description

Marketed without a 510K

Product

Arrow Temporary Pacing Catheter/Introducer Kit 6Fr. pacing catheter 7Fr. introducer Product Code: AI-06210-IK - Product Usage: intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording.

Manufacturer(s)

Arrow International Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →