Flexicare Medical Ltd.
FDA Regulatory Profile
Flexicare Medical Ltd. appears in FDA public data with 5 recalls — including 1 Class I (most serious) —, 7 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0497-2021, Class I) was initiated on September 22, 2020. Its most recent 510(k) clearance was granted on May 15, 2015.
Summary
- Total Recalls
- 5 (1 Class I)
- 510(k) Clearances
- 7
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0497-2021 | Class I | ProVu Single Use Video Stylet with ET Tube, Part/Size: 038-990-080U/ 8.0, 038-990-075U/ 7.5, 038-990 | September 22, 2020 |
| Z-0801-2020 | Class II | BriteBlade Pro Single-Use Fiber Optic Mac 3, CE01120, Do Not Re-use, Rx Only, REF 040-713U, Sterile | November 27, 2019 |
| Z-0804-2020 | Class II | BriteBlade Pro Single-Use Fiber Optic Handle and Blade Miller 2, CE 0120, Do not Re-use, Rx Only, RE | November 27, 2019 |
| Z-0803-2020 | Class II | BriteBlade Pro Single-Use Fiber Optic Handle and Blade Mac 3, CE 0120, Do not Re-use, Rx Only, REF, | November 27, 2019 |
| Z-0802-2020 | Class II | BriteBlade Pro Single-se Fiber Optic Miller 2, CE 0120, Do not Re-use, Rx Only, REF, 040-722U, Steri | November 27, 2019 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K150900 | Flexicare Heated Wire Breathing Systems | May 15, 2015 |
| K140473 | DUALGUARD | April 10, 2014 |
| K140113 | O2 NASAL CANNULA WITH CO2 MONITORING | March 6, 2014 |
| K132619 | CLASSIC INTERMITTENT CATHETER | October 11, 2013 |
| K092218 | FLEXICARE BREATHING FILTERS | October 6, 2009 |
| K091591 | FLEXICARE MEDICAL ENDOTRACHEAL TUBES | June 17, 2009 |
| K951652 | VENTIMASK MK IV | April 27, 1995 |