Z-1372-2015 Class II Terminated
FDA device recall Z-1372-2015 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: 58.
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
- 58
Product Description
Bio-PLASTY Cannula (Needle)
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 # BPC.45, BPC.60, BPC.80, and BPC.105