FDA Enforcement
Class II
Ongoing
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.
Recall: Z-2068-2021
·
Reported July 21, 2021
Enforcement
- Recall Number
- Z-2068-2021
- Event ID
- 88120
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Arrow International Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- July 21, 2021
- Initiation Date
- May 19, 2021
- Classification Date
- July 13, 2021
- Address
- 2400 Bernville Rd, Reading, PA, 19605-9607, United States
Description
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.
Reason
Marketed without a 510K
Code Info
Lot Numbers: 16F16F0057 16F19D0027 16F18B0040 16F19E0157 16F18E0121 16F19F0093 16F18F0058 16F19G0066 16F19C0082
Distribution
US Nationwide distribution in the states of FL, ID, IL, NY, OH, TX.
Quantity
48 units