T.A.L.O.N (Tactically Advanced Lifesaving Intraosseous Needle) 15G x 38.5 mm 10 NEEDLE SET STERILE EO Single Use Rx only
FDA device recall Z-1801-2015 · posted 2015-06-15 · Terminated
Recall details
- Recalling firm
- Vidacare Corporation
- Reason for recall
- Potential breach in sterility
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- FMI
- Quantity affected
- 2,104 boxes
- Distribution
- US Distribution to the states of : NC, MD, MS, TX and MO., and Internationally to Canada and Denmark.
- Date initiated
- 2015-05-12
- Date posted
- 2015-06-15
- Date terminated
- 2016-04-11
- Location
- Shavano Park, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| THE T.A.L.O.N. INTRAOSSOUS INFUSION SYSTEM BY VIDACRE (K120661) | Vidacare Corporation | 2012-06-03 |