Andover Healthcare Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 7
- 510(k) Clearances
- 1
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1828-2024 | Class II | Sterile CoFlex NL: Latex Free Flexible Cohesive Bandage, Tan, 4INx5YD (5400S) | April 2, 2024 |
| Z-0182-2020 | Class II | Sterile Co-Flex LF2 4" - Product Usage: Single Use secondary wound dressing or compression wrap | June 19, 2019 |
| Z-0181-2020 | Class II | Sterile Co-Flex LF2 3" - Product Usage: Single Use secondary wound dressing or compression wrap | June 19, 2019 |
| Z-0184-2020 | Class II | Sterile Co-Flex Med 4" - Product Usage: Single Use secondary wound dressing or compression wrap | June 19, 2019 |
| Z-0179-2020 | Class II | Sterile Co-Flex NL 3" - Product Usage: Single Use secondary wound dressing or compression wrap. | June 19, 2019 |
| Z-0180-2020 | Class II | Sterile Co-Flex NL 4" - Product Usage: Single Use secondary wound dressing or compression wrap | June 19, 2019 |
| Z-0183-2020 | Class II | Sterile Co-Flex Med 3" - Product Usage: Single Use secondary wound dressing or compression wrap | June 19, 2019 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K083133 | SILVERI: COFLEX AFD, COFLEX AFD FIRST AID, AFD PAD FOAM DRESSING, POWERFLEX AFD FOAM DRESSINGS | October 30, 2009 |