Device recall
Z-2171-2011: Ventricular Bolt Monitoring Kit W/Cranial Access, Drain, 1104HMC, Integra…
FDA device recall · Class II · Integra LifeSciences Corp.
Key facts
| Recall number (Z-number) | Z-2171-2011 |
|---|---|
| Recall event | 58216 |
| Product | Ventricular Bolt Monitoring Kit W/Cranial Access, Drain, 1104HMC, Integra LifeSciences, 3498 West 2400 South, West Valley City, Utah 84119. Kit contains components which are used to monitor Intra Cranial Pressure and provide access to the cerebral ventricles for Cerebro-spinal fluid sampling… |
| Product code | HBG |
| Recalling firm | Integra LifeSciences Corp. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 10, 2011 |
| 510(k) numbers | K961113 |
| FEI number | 3003418325 |
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