Vyaire Medical FDA Inspection Record
Vyaire Medical is an FDA-inspected facility (FEI 3002617992) located in Minneapolis, MN, US. RegDataLab tracks 4 FDA inspections at this facility.
What FDA found at this site
- Latest inspection
- Sep 30, 2014: No Action Indicated (NAI)
- Inspections on record
- 4 (1 VAI, 3 NAI)
- Last OAI inspection
- None on record
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
- Recalls as the recalling firm
- 2, latest Aug 8, 2014
- Import refusals
- 1
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Sep 30, 2014 | No Action Indicated (NAI) | No citations listed |
| Sep 5, 2012 | Voluntary Action Indicated (VAI) | Lack of or inadequate complaint procedures (21 CFR 820.198(a)) Design changes - Lack of or Inadequate Procedures (21 CFR 820.30(i)) Document change records, maintained. (21 CFR 820.40(b)) Nonconforming product, Lack of or inadequate procedures (21 CFR 820.90(a)) and 1 more |
| Nov 25, 2011 | No Action Indicated (NAI) | No citations listed |
| Sep 18, 2009 | No Action Indicated (NAI) | Investigation of device failures (21 CFR 820.198(c)) Documentation of disposition, justification, signature (21 CFR 820.90(b)(1)) Documentation (21 CFR 820.100(b)) General (21 CFR 820.198(a)) |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Aug 8, 2014 | Class I | Z-2593-2014 | CareFusion EnVe and ReVel Ventilators.
The EnVe/ ReVel Ventilator is designed for use… CareFusion has identified a potential for damage to the power connector on the EnVe and ReVel ventilators due to misconnection by the… |
| Jun 19, 2012 | Class I | Z-2006-2012 | CareFusion EnVe Ventilator
Designed for use on patients who require respiratory support… CareFusion identified that the EnVe Ventilator may not hold the set Positive End Expiratory Pressure (PEEP) value either intermittently or… |
FDA record score
0 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. Each record below adds the points shown.
3 records behind this number
| Record | Date | Points x age weight | Adds |
|---|---|---|---|
| Class I recall Z-2593-2014, this FEI as the recalling firm | Aug 8, 2014 | 10 years or older, so it adds no points | 0 |
| Inspection classified VAI | Sep 5, 2012 | 10 years or older, so it adds no points | 0 |
| Class I recall Z-2006-2012, this FEI as the recalling firm | Jun 19, 2012 | 10 years or older, so it adds no points | 0 |
When each source was last refreshed
| Records | Last refreshed | Source as of | Status |
|---|---|---|---|
| Inspections | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Inspection citations | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions (warning letters, injunctions and other action types) | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
| Warning letter text | Nov 14, 2026 | Newest record Nov 10, 2026 | Current |
| Recalls (Enforcement Report) | Nov 14, 2026 | Newest record Nov 11, 2026 | Current |
| Form 483s and inspection documents | Nov 13, 2026 | Newest record Nov 12, 2026 | Current |
| Import refusals | Nov 2, 2026 | Newest record Oct 22, 2026 | Current |
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Facility details
- Company
- Vyaire Medical
- Location
- Minneapolis, MN (US)
- Source
- inspections