Z-1373-2015 Class II Terminated
FDA device recall Z-1373-2015 was initiated by Biologic Therapies, Inc on January 23, 2015 and is designated Class II. Reason for recall: Devices are misbranded - failure to properly classify and obtain FDA clearance prior distribution The recall status is terminated (terminated August 6, 2015). Affected quantity: 2797 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 8, 2015
- Initiation Date
- January 23, 2015
- Termination Date
- August 6, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2797 units
Product Description
Bio-MAC Cannula (Needle) Set
Reason for Recall
Devices are misbranded - failure to properly classify and obtain FDA clearance prior distribution
Distribution Pattern
US Distribution in states of: MA, CA, WA, NJ, TX, IL, and FL.
Code Information
Catalog Numbers: Part # BMAC.25, BMAC.45, BMAC.60, BMAC.80, and BMAC.105