Device recall
Z-2260-2013: Cranial Access (CRAK) Kits, Product / Catalogue No.s: INSHITH, INSHITHND…
FDA device recall · Class II · Integra LifeSciences Corp. d.b.a. Integra Pain Management
Key facts
| Recall number (Z-number) | Z-2260-2013 |
|---|---|
| Recall event | 66186 |
| Product | Cranial Access (CRAK) Kits, Product / Catalogue No.s: INSHITH, INSHITHND, INSHITHRZN The kits allow for access to the subarachnoid space or the lateral ventricles of the brain. The kits are intended to be used with an external drainage and monitoring system in selected patients to reduce… |
| Product code | HGB |
| Recalling firm | Integra LifeSciences Corp. d.b.a. Integra Pain Management |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 28, 2014 |
| 510(k) numbers | K961113 |
| FEI number | 1000138491 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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