medical Class II Updated 2021-07-21

Arrow International Inc recalls Arrow Temporary Pacing Catheter/Introducer Kit 5Fr. pacing c

Recalled 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.

Hazard / Issue

Marketed without a 510K

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot Numbers: 23F20A0230 23F20E0004 23F20E0094
View official government recall

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