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Companies / Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 9
- 510(k) Clearances
- 0
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0585-2020 | Class II | 4Fr x 20cm Single Lumen CT Midline Basic Tray, Product Code: VYML4S1001 | September 24, 2019 |
| Z-0933-2018 | Class II | Vygon IV Start Convenience Kits; Product Codes AMS-623T and AMS-626TGSLF. Kit used when administ | October 3, 2017 |
| Z-0682-2018 | Class II | 3-Way Standardbore Stopcock. Product Code: AMS-100. | July 24, 2017 |
| Z-0678-2018 | Class II | Nutrisafe 2 35 mL Syringe for Safety Connection. Product Code: 1015.352M | July 24, 2017 |
| Z-0679-2018 | Class II | 20Ga x .75 LifeGuard Huber Needle with Y-site. Product Code: CLGY-2034. | July 24, 2017 |
| Z-0680-2018 | Class II | CVC Tray Pediatrics. Product Code: AMS-9335CP-2. | July 24, 2017 |
| Z-0681-2018 | Class II | 19Ga x 1 Huber Needle Set. Product Code: MBS-1910. | July 24, 2017 |
| Z-1484-2017 | Class II | AMS-636, 60" Microbore extension set. Product Usage: Accessory devices used to administer medica | February 20, 2017 |
| Z-0787-2017 | Class II | AMS-651, 120" Microbore extension set with slide clamp; Product Code: AMS-651 Product Usage: Acc | November 18, 2016 |