Recall Z-1373-2015 · FGY Cannula, Injection
Biologic Therapies, Inc
Bio-MAC Cannula (Needle) Set
| Date | Apr 2, 2015 (initiated Jan 23, 2015) |
| Status | Terminated |
| Reason | Devices are misbranded - failure to properly classify and obtain FDA clearance prior distribution |
| Root cause | Use error |
| Action | On January 23, 2015 the firm sent an URGENT: Class II MEDICAL DEVICE RECALL notification asking its consignees to: 1) Quarantine all remaining devices in their inventory and return the product to Biologic Therapies Inc. via UPS Ground. Product returns should be shipped under UPS Account #A197E9 and must reference RMA#15-0115-01. Please ship to the Biologic Therapies Inc. address listed at the bottom of Page 5. To coordinate return shipping, please contact Biologic Therapies, Inc. via the contact information provided.Contact hours: Monday - Friday 8am to 5pm Eastern Standard Time. (352) 304-5 |
| Quantity | 2797 units |
| Distribution | US Distribution in states of: MA, CA, WA, NJ, TX, IL, and FL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141910 | Intraosseous Cannula System Bio-MAC¿ and Bio-CORE Biologic Therapies, Inc., May 4, 2015 |