Western / Scott Fetzer Company
Western / Scott Fetzer Company appears in FDA public data with 7 recalls — including 1 Class I (most serious) —, 0 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent recall (Z-0340-2020, Class II) was initiated on August 15, 2019.
Summary
- Total Recalls
- 7 (1 Class I)
- 510(k) Clearances
- 0
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0340-2020 | Class II | Grab n Go Opti series VIPR system Model # PRX-9627 - Product Usage: The Grab n Go Opti system is a | August 15, 2019 |
| Z-0339-2020 | Class II | Grab n Go Opti series VIPR system Model # PRX-9615 - Product Usage: The Grab n Go Opti system is a | August 15, 2019 |
| Z-0342-2020 | Class II | Grab n Go Opti series VIPR system Model # PRX-9646 - Product Usage: The Grab n Go Opti system is a | August 15, 2019 |
| Z-0341-2020 | Class II | Grab n Go Opti series VIPR system Model # PRX-9632 - Product Usage: The Grab n Go Opti system is a | August 15, 2019 |
| Z-0343-2020 | Class II | Grab n Go Opti series VIPR system Model # PRX-9653 - Product Usage: The Grab n Go Opti system is a | August 15, 2019 |
| Z-2069-2015 | Class I | Various OxyTOTE Portable Oxygen System regulators, Valve Integrated Pressure Regulator, one unit per | January 31, 2015 |
| Z-1849-2014 | Class II | Model RG3000 and RG4000 Series Valve Integrated Pressure Regulator (VIPR) | April 7, 2014 |