medical Class II Updated 2021-07-21

Arrow International Inc recalls Arrow Bipolar Balloon Electrode Catheter 5 Fr. 105 cm, Produ

Recalled Product

Arrow Bipolar Balloon Electrode Catheter 5 Fr. 105 cm, Product Code: AI-07154 - 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: 16F19J0109
View official government recall

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