Device recall
Z-1237-2016: UltraxxTM Nephrostomy Balloon Set The Ultraxx" Nephrostomy Balloon Set consists…
FDA device recall · Class II · Cook Inc.
Key facts
| Recall number (Z-number) | Z-1237-2016 |
|---|---|
| Recall event | 73398 |
| Product | UltraxxTM Nephrostomy Balloon Set The Ultraxx" Nephrostomy Balloon Set consists of a radiopaque balloon catheter, radiopaque sheath, and inflation device. The Ultraxx" Nephrostomy Balloon Set is used to dilate the musculofascia, renal capsule, and parenchyma to establish and maintain a percutaneous… |
| Product code | LJE |
| Recalling firm | Cook Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 17, 2017 |
| 510(k) numbers | K024050 |
| FEI number | 1820334 |
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