BEUDAMED
    FDA Enforcement Class II Terminated

    REF CMS-CT6T225, 6F Triple Lumen CT PICC with M.S.T. Components Product Usage: Power injectable infusion PICC insertion kits

    Recall: Z-0898-2013 · Reported March 6, 2013

    Enforcement

    Recall Number
    Z-0898-2013
    Event ID
    64235
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medical Components, Inc dba MedComp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 6, 2013
    Initiation Date
    December 13, 2012
    Classification Date
    February 28, 2013
    Termination Date
    July 31, 2013
    Address
    1499 Delp Dr, N/A, Harleysville, PA, 19438, United States

    Description

    REF CMS-CT6T225, 6F Triple Lumen CT PICC with M.S.T. Components Product Usage: Power injectable infusion PICC insertion kits

    Reason

    The affected 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

    USA Nationwide Distribution including the state of PA.

    Quantity

    785