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Companies / Arrow International, Inc., Division of Teleflex Medical Inc.
Arrow International, Inc., Division of Teleflex Medical Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 9 (9 Class I)
- 510(k) Clearances
- 0
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1055-2016 | Class I | FiberOptix Ultra 8 IAB: 8Fr 30cc The Arrow¿ IAB is utilized for intra aortic balloon counterpulsa | February 10, 2016 |
| Z-1063-2016 | Class I | Percutaneous Insertion Tray; Product Code: IAK-S7IT The Arrow¿ IAB is utilized for intra aortic b | February 10, 2016 |
| Z-1058-2016 | Class I | Ultra 8 IAB: 8Fr 40cc; Product Code: IAB-05840-U The Arrow¿ IAB is utilized for intra aortic ball | February 10, 2016 |
| Z-1056-2016 | Class I | Ultra 8 IAB: 8Fr 30cc; Product Code: IAB-05830-U The Arrow¿ IAB is utilized for intra aortic ball | February 10, 2016 |
| Z-1057-2016 | Class I | FiberOptix Ultra 8 IAB: 8Fr 40cc; Product Code: IAB-05840-LWS The Arrow¿ IAB is utilized for intr | February 10, 2016 |
| Z-1061-2016 | Class I | RediGuard IAB: 7Fr 30cc; Product Code: IAB-S730C The Arrow¿ IAB is utilized for intra aortic ball | February 10, 2016 |
| Z-1062-2016 | Class I | Percutaneous Insertion Tray; Product Code: IAK-06845 The Arrow¿ IAB is utilized for intra aortic | February 10, 2016 |
| Z-1060-2016 | Class I | UltraFlex IAB: 7.5Fr 40cc; Product Code: IAB-06840-U The Arrow¿ IAB is utilized for intra aortic | February 10, 2016 |
| Z-1059-2016 | Class I | UltraFlex IAB: 7.5Fr 30cc; Product Code: IAB-06830-U The Arrow¿ IAB is utilized for intra aortic | February 10, 2016 |