BEUDAMED
    FDA Recall Terminated

    ChemoSite Low Profile, Implantable Low Profile Mini Catheter Venous Access System with printed Polyurethane Catheter and 7 French Introducer Kit Catalog Number: 120011

    Recall: Z-1091-05 · Initiated June 30, 2005

    Recall

    Recall Number
    Z-1091-05
    Event Number
    32569
    Firm
    United States Surgical Corporation
    FEI Number
    1219930
    Product Code
    LJS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 30, 2005
    Posted
    August 6, 2005
    Terminated
    September 14, 2010
    Address
    195 Mcdermott Rd, North Haven, CT, 06473-3665

    Description

    ChemoSite Low Profile, Implantable Low Profile Mini Catheter Venous Access System with printed Polyurethane Catheter and 7 French Introducer Kit Catalog Number: 120011

    Reason

    The peel away introducer sheath may have cracked hubs/handles and /or improper peeling of the sheath during use

    Action

    United States Surgical notified customers by letter dated June 30, 2005 requesting return of the recalled product.

    Distribution

    Nationwide Foreign: Australia, Canada, Germany,Israel, Uruguay, Chile,

    Quantity

    266 units