BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-1097-04 · Initiated March 19, 2003

    Recall

    Recall Number
    Z-1097-04
    Event Number
    25912
    Firm
    Integra Life Sciences Corp.
    FEI Number
    1000125384
    Product Code
    HCA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 19, 2003
    Posted
    July 20, 2004
    Terminated
    August 5, 2004
    Address
    309 Commerce Dr, Exton, PA, 19341

    Description

    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.

    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.

    Action

    The recalling firm telephoned the customer on 3/19/03. The recalling firm followed up with a recall letter on 3/24/03.

    Distribution

    The product was shipped to one hospital in NY.

    Quantity

    6 kits