Device product
Tissu-Trans Filtron 1000 Catalog Number 3-TT-FILTRON 1000. Used for fat transfer and liposuction.
Z-0170-2018
Product summary
- Event
- Event 78392
- Status
- Terminated
- Classification
- Class II
- Quantity
- 56 units
- Official record key
device-enforcement:Z-0170-2018
Official wording
Reason: Potential breach of sterility of the packaging.
Code information: Lot 12004
Distribution pattern: Worldwide Distribution -- United States, Australia, and Netherlands.
Derived failure modes
-
Sterility assurance
breach of sterility