BEUDAMED
    FDA Enforcement Class II Terminated

    Duo-Flow IJ Full Tray; MCDLT114IJ MCDLT116IJ MCDLT118IJ

    Recall: Z-2935-2018 · Reported September 5, 2018

    Enforcement

    Recall Number
    Z-2935-2018
    Event ID
    80581
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medical Components, Inc dba MedComp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 5, 2018
    Initiation Date
    July 12, 2018
    Classification Date
    August 25, 2018
    Termination Date
    July 2, 2020
    Address
    1499 Delp Dr, N/A, Harleysville, PA, 19438-2936, United States

    Description

    Duo-Flow IJ Full Tray; MCDLT114IJ MCDLT116IJ MCDLT118IJ

    Reason

    The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 broken suture wings) to date for malfunction, without serious injury or death.

    Code Info

    MCBA810 MCBS660 MCAX580 MCBH13D MCBKOlO MCBN350 MCBY390 MCCV240 MCDA860 MCDG370 MCDJ730 MCDP710 MCFA850 MCFB360 MCFD630 MCFM700 MCFS710 MCFX790 MKAD790 MKAG470 MKAT090 MKAX630 MCBA820 MCBYS20 MCCP980 MCFD640 MCFQ350 MKAR100 MCAC610 MCAT590 MCCH750 MCDQ920 MCFV690 MCAH750 MCFZ550

    Distribution

    Nationwide distribution; worldwide distribution.

    Quantity

    N/A