Recall Z-1097-04 ยท HCA Catheter, Ventricular
Integra Life Sciences Corp.
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.
| Date | Jul 20, 2004 (initiated Mar 19, 2003) |
| Status | Terminated |
| Reason | The outer labeling of the convenience kit indicates that an additional bottle of Sodium Chloride (saline) solution is included in the Custom Kit 31176; however, an additional bottle of 1% Xylocaine was included in the Custom Kit. |
| Root cause | Other |
| Action | The recalling firm telephoned the customer on 3/19/03. The recalling firm followed up with a recall letter on 3/24/03. |
| Quantity | 6 kits |
| Distribution | The product was shipped to one hospital in NY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K961113 | CNS INTERCHANGEABLE BIT CRANIAL DRILL Clinical Neuro Systems, LLC, Jun 5, 1996 |