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AccessClosure, Inc., A Cardinal Health Company
FDA Regulatory Profile
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 0
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0297-2017 | Class II | The PAXWIRE Occlusion Balloon System consists of an occlusion catheter, inflation handle and syringe | October 6, 2016 |
| Z-2329-2016 | Class II | 6F/7F MynxGrip Vascular Closure Device; Product Model MX6721, Product Usage: The 6F/7F MynxGrip | July 13, 2016 |