BEUDAMED
    FDA Enforcement Class II Terminated

    Hickman 9.0 French Dual Lumen Catheter with SureCuff Tissue Ingrowth Cuff with Peel-Apart Percutaneous Introducer system (pediatric product code 0600580; adult product code 0600600). Product Usage: Hickman and Leonard Catheters are designed for long-term vascular access and for use in patients that lack adequate peripheral venous access.

    Recall: Z-0909-2013 · Reported March 13, 2013

    Enforcement

    Recall Number
    Z-0909-2013
    Event ID
    64425
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Bard Access Systems
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 13, 2013
    Initiation Date
    February 21, 2013
    Classification Date
    March 5, 2013
    Termination Date
    January 3, 2014
    Address
    605 North 5600 West, N/A, Salt Lake City, UT, 84116-3738, United States

    Description

    Hickman 9.0 French Dual Lumen Catheter with SureCuff Tissue Ingrowth Cuff with Peel-Apart Percutaneous Introducer system (pediatric product code 0600580; adult product code 0600600). Product Usage: Hickman and Leonard Catheters are designed for long-term vascular access and for use in patients that lack adequate peripheral venous access.

    Reason

    Bard Access Systems is recalling two lots of Hickman 9.0 French and one lot of Leonard 10.0 French Dual Lumen Catheters with SureCuff Tissue Ingrowth Cuff with Peel-Apart Percutaneous Introducer Systems due to the wrong size introducer being included with the kit.

    Code Info

    Lot numbers: HUWI1379 and HUWI1380.

    Distribution

    USA Nationwide Distribution and the countries Europe, Belgium, Australia, and Latin America.

    Quantity

    195 units.