Recall Z-1372-2015— Biologic Therapies, Inc
Class II · Terminated
Class II FDA medical device recall by Biologic Therapies, Inc, initiated 2015-01-23, terminated 2015-08-06. FDA's recall record names no specific 510(k) clearance for this event. Product: Bio-PLASTY Cannula (Needle). Reason: Devices are misbranded - failure to properly classify and obtain FDA clearance prior distribution.
- Recalling firm
- Biologic Therapies, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-01-23
- Terminated
- 2015-08-06
- Firm location
- Ocala, FL, United States
Product description
Bio-PLASTY Cannula (Needle)
Reason for recall
Devices are misbranded - failure to properly classify and obtain FDA clearance prior distribution
Data sourced from openFDA. This site is unofficial and independent of the FDA.