Device recall
Z-1047-201: "***REF NL78013-01***INTEGRA NEUROSCIENCES***Stylet for Ventricular…
FDA device recall · Class II · Integra Neurosciences PR, Inc.
Key facts
| Recall number (Z-number) | Z-1047-201 |
|---|---|
| Recall event | 60599 |
| Product | "***REF NL78013-01***INTEGRA NEUROSCIENCES***Stylet for Ventricular Catheter***Non Sterile for Single Use Only***Size 0.031" OD, Total Length: 8"***Plainsboro, NJ***" Stainless steel stylet for ventricular catheter |
| Product code | JXG |
| Recalling firm | Integra Neurosciences PR, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 29, 2013 |
| 510(k) numbers | K811288 |
| FEI number | 3000204775 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 Products in the same recall event
- 100–999 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