Device product
Bio-CORE Cannula (Needle) Set
Z-1374-2015
Product summary
- Event
- Event 70445
- Status
- Terminated
- Classification
- Class II
- Quantity
- 0 (distributed or released)
- Official record key
device-enforcement:Z-1374-2015
Official wording
Reason: Devices are misbranded - failure to properly classify and obtain FDA clearance prior distribution
Code information: Catalog Numbers: Part # BCORE.60, BCORE.80, and BCORE.105
Distribution pattern: US Distribution in states of: MA, CA, WA, NJ, TX, IL, and FL.
Derived failure modes
-
Labeling or packaging
misbranded