Device recall
Z-1984-2012: Pudenz Flushing Valve with Integral Connectors, catalog number NL850-1330…
FDA device recall · Class II · Integra LifeSciences Corp
Key facts
| Recall number (Z-number) | Z-1984-2012 |
|---|---|
| Recall event | 62138 |
| Product | Pudenz Flushing Valve with Integral Connectors, catalog number NL850-1330. Integra Neurosciences, Plainsboro, NJ. Device is used for the treatment of hydrocephalic patients when shunting cerebrospinal fluid from the ventricles of the brain. |
| Product code | JXG |
| Recalling firm | Integra LifeSciences Corp |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 2, 2012 |
| 510(k) numbers | K760501 |
| FEI number | 1121308 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 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