BEUDAMED
    FDA Recall 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 · Initiated December 17, 2012

    Recall

    Recall Number
    Z-0937-2013
    Event Number
    64458
    Firm
    Vygon Corporation
    FEI Number
    2245270
    Product Code
    LJS
    Status
    Terminated
    Root Cause
    Component change control
    Initiated
    December 17, 2012
    Posted
    March 11, 2013
    Terminated
    January 14, 2014
    Address
    2750 Morris Rd, Ste A200, Lansdale, PA, 19446-6083

    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.

    Action

    Churchill Medical Systems sent a letter to their consignees on December 19, 2012.

    Distribution

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

    Quantity

    210