Arrow International Inc recalls Arrow Temporary Pacing Catheter/Introducer Kit 5Fr. pacing catheter 6 Fr. introducer Product Code: AI-07155-IK - Produ

Recalled July 21, 2021 · FDA recall Z-2071-2021 · Arrow International

Hazard

Marketed without a 510K · FDA Class II

Units

15 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 5Fr. pacing catheter 6 Fr. introducer Product Code: AI-07155-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 →