Device recall
Z-1097-04: Cranial Access Kit (INS-HITH) included in External CSF Drainage Kit convenience…
FDA device recall · Class II · Integra Life Sciences Corp.
Key facts
| Recall number (Z-number) | Z-1097-04 |
|---|---|
| Recall event | 25912 |
| Product | Cranial Access Kit (INS-HITH) included in External CSF Drainage Kit convenience Kit #31176. The kit contains: one Hermetic Large Style Ventricular Catheter Set, one Ventricular Drainage System, one INS-HITH Cranial Access Kit, one Sodium Chloride 10 ml, and one Suture 2-0 silk. |
| Product code | HCA |
| Recalling firm | Integra Life Sciences Corp. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 5, 2004 |
| 510(k) numbers | K961113 |
| FEI number | 1000125384 |
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