Barton-Carey Medical Products Co. FDA Record
- Latest inspection NAI · May 20, 2025
- Last warning letter 2012
Barton-Carey Medical Products Co. has 0 FDA recalls, 5 inspections, 1 510(k) clearance and 1 compliance action on record. FDA has issued 1 warning letter to Barton-Carey Medical Products Co., the most recent on Dec 10, 2012.
- Latest inspection
- May 20, 2025 · NAI
- Latest 510(k)
- Feb 13, 1986
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 1 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 5 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 1 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Barton-Carey Medical Products Co. FDA Warning Letters
| Issued | Subject | Issuing office | Close-out letter |
|---|---|---|---|
| Dec 10, 2012 · Record page |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| May 20, 2025 | Jellico, TN | Devices | No Action Indicated (NAI) | 3003070670 |
| Mar 14, 2014 | Maumee, OH | Devices | Voluntary Action Indicated (VAI) | 1527179 |
| Aug 10, 2012 | Maumee, OH | Devices | Official Action Indicated (OAI) | 1527179 |
| Apr 3, 2012 | Jellico, TN | Devices | No Action Indicated (NAI) | 3003070670 |
| Sep 4, 2009 | Maumee, OH | Devices | Voluntary Action Indicated (VAI) | 1527179 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
Compliance Actions
FDA's compliance actions data lists 1 compliance action under Barton-Carey Medical Products Co.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3003070670 | Jellico, TN | 2 | May 20, 2025 |
| FEI 1527179 | Maumee, OH | 3 | Mar 14, 2014 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K854428 | VASC-EZ | Feb 13, 1986 |
Barton-Carey Medical Products Co. and the FDA: common questions
Has Barton-Carey Medical Products Co. received an FDA warning letter?
Yes. FDA has issued 1 warning letter to Barton-Carey Medical Products Co.. The most recent is dated Dec 10, 2012.
Has Barton-Carey Medical Products Co. received an FDA Form 483?
FDA has not published a Form 483 for "Barton-Carey Medical Products Co." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Barton-Carey Medical Products Co.?
The most recent FDA inspection on file ended May 20, 2025 at Jellico, TN and was classified NAI. FDA has 5 inspections of Barton-Carey Medical Products Co. on file, 1 of them classified OAI (official action indicated).
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