Device product
Bio-MAC Cannula (Needle) Set
Z-1373-2015
Product summary
- Event
- Event 70445
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2797 units
- Official record key
device-enforcement:Z-1373-2015
Official wording
Reason: Devices are misbranded - failure to properly classify and obtain FDA clearance prior distribution
Code information: Catalog Numbers: Part # BMAC.25, BMAC.45, BMAC.60, BMAC.80, and BMAC.105
Distribution pattern: US Distribution in states of: MA, CA, WA, NJ, TX, IL, and FL.
Derived failure modes
-
Labeling or packaging
misbranded