Recall Z-2071-2021— Arrow International Inc
Class II · Ongoing
Class II FDA medical device recall by Arrow International Inc, initiated 2021-05-19. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Marketed without a 510K.
- Recalling firm
- Arrow International Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2021-05-19
- Firm location
- Reading, PA, United States
Product description
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.
Reason for recall
Marketed without a 510K
Data sourced from openFDA. This site is unofficial and independent of the FDA.