BEUDAMED
    FDA Enforcement Class II Terminated

    Churchill Medical Systems, Inc. A Vygon Company - All sizes of CMS-CT6T225 6F Triple Lumen CT PICC with M.S.T. Components, Peripherally Inserted Central Catheter.

    Recall: Z-0937-2013 · Reported March 20, 2013

    Enforcement

    Recall Number
    Z-0937-2013
    Event ID
    64458
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Vygon Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 20, 2013
    Initiation Date
    December 17, 2012
    Classification Date
    March 11, 2013
    Termination Date
    January 14, 2014
    Address
    2750 Morris Rd Ste A200, N/A, Lansdale, PA, 19446-6083, United States

    Description

    Churchill Medical Systems, Inc. A Vygon Company - All sizes of CMS-CT6T225 6F Triple Lumen CT PICC with M.S.T. Components, Peripherally Inserted Central Catheter.

    Reason

    Product was packaged with the incorrect introducer needle. The kit label indicates a "safety" needle is included; the kits were packaged with a non-safety needle.

    Code Info

    Lots numbers MBKQ640, exp 05/2015; MBKZ720, exp 05/2015; MBLJ290, exp 06/2015; MBLR100, exp 07/2015; MBLZ350, exp 09/2015; and MBMG250, exp 10/2015.

    Distribution

    Product was distributed to 4 hospitals (under one hospital network) within the State of Pennsylvania

    Quantity

    210