Z-2070-2021 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- July 21, 2021
- Initiation Date
- May 19, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4 units
Product Description
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.
Reason for Recall
Marketed without a 510K
Distribution Pattern
US Nationwide distribution in the states of FL, ID, IL, NY, OH, TX.
Code Information
Lot Numbers: 16F19J0109