Western/Scott Fetzer Company
FDA Regulatory Profile
Western/Scott Fetzer Company appears in FDA public data with 5 recalls, 1 510(k) clearance, 4 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-1376-2023, Class II) was initiated on January 3, 2023. Its most recent 510(k) clearance was granted on April 17, 2015.
Summary
- Total Recalls
- 5
- 510(k) Clearances
- 1
- Inspections
- 4
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1376-2023 | Class II | Digital VIPR ROC-9839 Roberts Oxygen Ready to Use Digital VIPR (head only) ROC-9840, Roberts Oxy | January 3, 2023 |
| Z-0268-2022 | Class II | Western Oxytote DTE Digital VIPR (head only) Model: MNDR-600 | October 16, 2021 |
| Z-0270-2022 | Class II | Western Oxytote DTE Digital VIPR System (with E-size cylinder) Model: MNDS-603 | October 16, 2021 |
| Z-0267-2022 | Class II | Roberts Digital VIPR System (with E-size cylinder) Model: ROC-9840 | October 16, 2021 |
| Z-0269-2022 | Class II | Western Oxytote DTE Digital VIPR System (with D-size cylinder) Model: MNDS-602 | October 16, 2021 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K142149 | OXYTOTE INFINITY SERIES VIPR SYSTEMS | April 17, 2015 |