Device recall
Z-0215-2015: AxoTrack I Sterile Procedure Kit 18G, K1001-18XTW, (24/case labeled for US…
FDA device recall · Class II · Soma Access Systems LLC
Key facts
| Recall number (Z-number) | Z-0215-2015 |
|---|---|
| Recall event | 69619 |
| Product | AxoTrack I Sterile Procedure Kit 18G, K1001-18XTW, (24/case labeled for US, 5/case labeled for US, 24/case labeled for EU, 5/case labeled for EU). Sterile Procedure Kit for use AxoTrack enabled Ultrasound Transducer for magnetic needle tracking. |
| Product code | IYO |
| Recalling firm | Soma Access Systems LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 6, 2015 |
| 510(k) numbers | K113680 |
| FEI number | 3009436116 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database