BEUDAMED
    FDA Recall Terminated

    StatLock Tandem Microbore Catheter Extension Set with preattached Clearlink Valve 6'' LL. Model number 2N9205K.

    Recall: Z-0925-03 · Initiated May 12, 2003

    Recall

    Recall Number
    Z-0925-03
    Event Number
    26365
    Firm
    Venetec Intl Inc
    FEI Number
    1000117366
    Product Code
    FPA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 12, 2003
    Posted
    June 12, 2003
    Terminated
    October 14, 2003
    Address
    12555 High Bluff Dr, Ste 170, San Diego, CA, 92130

    Description

    StatLock Tandem Microbore Catheter Extension Set with preattached Clearlink Valve 6'' LL. Model number 2N9205K.

    Reason

    Set tubing disconnected from the male luer lock during use on patients. Misassembled.

    Action

    A recall letter was sent to the distributor who then sent thier own letters to the affected hospitals. Hospitals were reached on or about May 14, 2003 whereas the distributor was contacted by telephone and letter on or about May 12, 2003. It was verbally agreed that the distributor would subrecall the product.

    Distribution

    One distributor sent the product to 6 hospitals in the states of CT, IN, PA, TN.

    Quantity

    3150 units