medical Class II Updated 2021-07-21

Arrow International Inc recalls Arrow Temporary Pacing Catheter/Introducer Kit 6Fr. pacing c

Recalled 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.

Hazard / Issue

Marketed without a 510K

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot Numbers: 16F20C0035 16F20F0124
View official government recall

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