BEUDAMED
    FDA Recall Terminated

    Ventra Percutaneous Intravenous Catheter Repair Kit for 11 French Triple-Lumen External Catheter Segment, Reorder Number 21-0107

    Recall: Z-1068-03 · Initiated July 8, 2003

    Recall

    Recall Number
    Z-1068-03
    Event Number
    26715
    Firm
    Deltec, Inc
    FEI Number
    2183502
    Product Code
    FOZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 8, 2003
    Posted
    July 30, 2003
    Terminated
    July 2, 2004
    Address
    1265 Grey Fox Road, St Paul, MN, 55112

    Description

    Ventra Percutaneous Intravenous Catheter Repair Kit for 11 French Triple-Lumen External Catheter Segment, Reorder Number 21-0107

    Reason

    Silicone adhesive in kits used to repair damaged catheters did not set (cure) properly and remained in a tacky state.

    Action

    A recall letter, sent to the consignees on July 8, 2003, gave them the option of returning the kits or waiting for the firm to provide them with replacement silicone adhesive.

    Distribution

    The product was shipped to 14 consignees (hospitals) in California, Illinois, Kansas, Michigan, Minnesota, Missouri, Pennsylvania, and Texas.