medical Class II Updated 2021-07-21

Arrow International Inc recalls Arrow Pacing Catheter Kit-Bipolar Electrode Catheter 5 Fr. 1

Recalled Product

Arrow Pacing Catheter Kit-Bipolar Electrode Catheter 5 Fr. 110 cm, Product Code: AI-05210 - 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: 16F16F0057 16F19D0027 16F18B0040 16F19E0157 16F18E0121 16F19F0093 16F18F0058 16F19G0066 16F19C0082
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