Device product
Bio-PLASTY Cannula (Needle)
Z-1372-2015
Product summary
- Event
- Event 70445
- Status
- Terminated
- Classification
- Class II
- Quantity
- 58
- Official record key
device-enforcement:Z-1372-2015
Official wording
Reason: Devices are misbranded - failure to properly classify and obtain FDA clearance prior distribution
Code information: Catalog Numbers: Part # BPC.45, BPC.60, BPC.80, and BPC.105
Distribution pattern: US Distribution in states of: MA, CA, WA, NJ, TX, IL, and FL.
Derived failure modes
-
Labeling or packaging
misbranded