Recall Z-1801-2015 ยท FMI Needle, Hypodermic, Single Lumen
Vidacare Corporation
T.A.L.O.N (Tactically Advanced Lifesaving Intraosseous Needle) 15G x 38.5 mm 10 NEEDLE SET STERILE EO Single Use Rx only Vidacare Corporation
| Date | Jun 15, 2015 (initiated May 12, 2015) |
| Status | Terminated |
| Reason | Potential breach in sterility |
| Root cause | Device Design |
| Action | Teleflex sent an Urgent Medical Recall Notification dated May 12, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter directed the customers to quarantine the affected product and return it to the manufacturer. If you have any further questions please call 1-866-246-6990. |
| Quantity | 2,104 boxes |
| Distribution | US Distribution to the states of : NC, MD, MS, TX and MO., and Internationally to Canada and Denmark. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120661 | THE T.A.L.O.N. INTRAOSSOUS INFUSION SYSTEM BY VIDACRE Vidacare Corporation, Jun 3, 2012 |