BEUDAMED
    FDA Enforcement Class II Terminated

    DUO FLOW CUSTOM TRAYS; TRAY #414 TRAY #415 TRAY #67

    Recall: Z-2941-2018 · Reported September 5, 2018

    Enforcement

    Recall Number
    Z-2941-2018
    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 CUSTOM TRAYS; TRAY #414 TRAY #415 TRAY #67

    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

    MCBC900 MCBP350 MCDC900 MCGA140 MCCD760 MKAL320 MCAS020 MCCF310 MCCV750 MCCV870 MCDL720 MCDV440 MCFJ760 MKAF680

    Distribution

    Nationwide distribution; worldwide distribution.

    Quantity

    N/A