Arrow Temporary Pacing Catheter Kit Recalled for Marketing Without FDA 510K Clearance
Arrow International is recalling its Temporary Pacing Catheter/Introducer Kit (5 units) because it was marketed without FDA 510K clearance. Affected lot numbers: 16F20C0035 and 16F20F0124.
- Product
- Arrow Temporary Pacing Catheter/Introducer Kit 6Fr. pacing catheter 7Fr. introducer Product Code: AI-06210-IK - Product Usage: intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording.
- Category
- Medical Device
- Distribution
- Distributed nationwide