Device product
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
Z-1801-2015
Product summary
- Event
- Event 71247
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,104 boxes
- Official record key
device-enforcement:Z-1801-2015
Official wording
Reason: Potential breach in sterility
Code information: 3103376, 3103377, 3103378, 3524557, 3547157, 3693167, 3843307, 3868998, 3986753, 3991994, 3991995, 3999583, 4011996, 4023525, 4040723, 4040724
Distribution pattern: US Distribution to the states of : NC, MD, MS, TX and MO., and Internationally to Canada and Denmark.
Derived failure modes
-
Sterility assurance
breach in sterility