Care Essentials Pty., Ltd.
FDA Regulatory Profile
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 4
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0987-2020 | Class II | Cocoon Convective Warming System, Product Code: CWS5000 (110V). | January 7, 2020 |
| Z-0986-2020 | Class II | Cocoon Convective Warming System, Product Code: CWS4000 (110V). | January 7, 2020 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K232502 | Cocoon Convective Warming System, Model CWS7000 | February 21, 2024 |
| K213907 | CareGUARD Sterilization Wrap | March 14, 2022 |
| K181671 | Cocoon Convective Warming System | May 2, 2019 |
| K140635 | COCOON CONVECTIVE WARMING SYSTEM | July 25, 2014 |