Vygon MFG, Inc., Dba/ Churchill Medical Systems, Inc. FDA Record
- No warning letters matched by name
Vygon MFG, Inc., Dba/ Churchill Medical Systems, Inc. has 9 FDA recalls, 0 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Vygon MFG, Inc., Dba/ Churchill Medical Systems, Inc." is on file.
- Latest recall
- Z-0585-2020 · Class II · Sep 24, 2019
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 9 | Nov 11, 2026 (checked Nov 15, 2026, unchanged) | File dated Nov 10, 2026 | Current |
| 510(k) clearances | 0 | Nov 15, 2026 | File dated Nov 9, 2026 | Current |
| Inspections | 0 | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
Vygon MFG, Inc., Dba/ Churchill Medical Systems, Inc.: FDA recall records per year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 1 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2017 | 0 | 0 | 0 | 7 | 0 |
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Recent recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0585-2020 | Class II | 4Fr x 20cm Single Lumen CT Midline Basic Tray, Product Code: VYML4S1001 | Sep 24, 2019 |
| Z-0933-2018 | Class II | Vygon IV Start Convenience Kits; Product Codes AMS-623T and AMS-626TGSLF. Kit used when… | Oct 3, 2017 |
| Z-0678-2018 | Class II | Nutrisafe 2 35 mL Syringe for Safety Connection. Product Code: 1015.352M | Jul 24, 2017 |
| Z-0681-2018 | Class II | 19Ga x 1 Huber Needle Set. Product Code: MBS-1910. | Jul 24, 2017 |
| Z-0679-2018 | Class II | 20Ga x .75 LifeGuard Huber Needle with Y-site. Product Code: CLGY-2034. | Jul 24, 2017 |
| Z-0682-2018 | Class II | 3-Way Standardbore Stopcock. Product Code: AMS-100. | Jul 24, 2017 |
| Z-0680-2018 | Class II | CVC Tray Pediatrics. Product Code: AMS-9335CP-2. | Jul 24, 2017 |
| Z-1484-2017 | Class II | AMS-636, 60" Microbore extension set. Product Usage: Accessory devices used to administer… | Feb 20, 2017 |
| Z-0787-2017 | Class II | AMS-651, 120" Microbore extension set with slide clamp; Product Code: AMS-651 Product Usage… | Nov 18, 2016 |
Vygon MFG, Inc., Dba/ Churchill Medical Systems, Inc. and the FDA: common questions
Has Vygon MFG, Inc., Dba/ Churchill Medical Systems, Inc. received an FDA warning letter?
No FDA warning letter addressed to the name "Vygon MFG, Inc., Dba/ Churchill Medical Systems, Inc." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Vygon MFG, Inc., Dba/ Churchill Medical Systems, Inc. received an FDA Form 483?
FDA has not published a Form 483 for "Vygon MFG, Inc., Dba/ Churchill Medical Systems, Inc." in its reading room. FDA publishes some Form 483s, not all of them.
Has Vygon MFG, Inc., Dba/ Churchill Medical Systems, Inc. had an FDA recall?
Yes. Vygon MFG, Inc., Dba/ Churchill Medical Systems, Inc. has 9 FDA recalls on record. The most recent started Sep 24, 2019.
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