FDA Enforcement
Class II
Terminated
Bio-CORE Cannula (Needle) Set
Recall: Z-1374-2015
·
Reported April 8, 2015
Enforcement
- Recall Number
- Z-1374-2015
- Event ID
- 70445
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Biologic Therapies, Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 8, 2015
- Initiation Date
- January 23, 2015
- Classification Date
- April 2, 2015
- Termination Date
- August 6, 2015
- Address
- 5817 Nw 44th Ave, N/A, Ocala, FL, 34482-7891, United States
Description
Bio-CORE Cannula (Needle) Set
Reason
Devices are misbranded - failure to properly classify and obtain FDA clearance prior distribution
Code Info
Catalog Numbers: Part # BCORE.60, BCORE.80, and BCORE.105
Distribution
US Distribution in states of: MA, CA, WA, NJ, TX, IL, and FL.
Quantity
0 (distributed or released)