BEUDAMED
    FDA Enforcement Class II Terminated

    Double Lumen CRRT/ABP Catheter Set; Hemodialysis catheter insertion kits, DL 11/15 DL 11/20 DL 9/15

    Recall: Z-2933-2018 · Reported September 5, 2018

    Enforcement

    Recall Number
    Z-2933-2018
    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

    Double Lumen CRRT/ABP Catheter Set; Hemodialysis catheter insertion kits, DL 11/15 DL 11/20 DL 9/15

    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

    MCAJ510 MCAP860 MCAZ820 MCCB890 MCCJ250 MCDF160 MCDQ630 MCFF200 MCFF620 MCFK200 MCFV440 MKAK310 MCAW770 MCBW430 MCCH320 MCCJ690 MCFB450 MCFF930 MCFV450 MKAK320 MKAV210 MCAY080 MCBD600 MCBP740 MCBW440 MCCA030 MCCH330

    Distribution

    Nationwide distribution; worldwide distribution.

    Quantity

    N/A