Device recall
Z-0106-2021: Pediatric Nephrostomy Stent Set, Reference Part Numbers 080208-S6 and 080208-S7…
FDA device recall · Class II · Cook Inc.
Key facts
| Recall number (Z-number) | Z-0106-2021 |
|---|---|
| Recall event | 86411 |
| Product | Pediatric Nephrostomy Stent Set, Reference Part Numbers 080208-S6 and 080208-S7, Order Numbers G15034 and G15035. The set contains a radiopaque pigtail catheter and stent, retention disc with pull tie, and a 10 French, 30 cm polyvinylchloride connecting tube with one-way stopcock. |
| Product code | LJE |
| Recalling firm | Cook Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 1, 2021 |
| 510(k) numbers | K181735 |
| 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