BEUDAMED
    FDA Enforcement Class II Terminated

    SOFT-LINE DUO-FLOW DOUBLE LUMEN CATHETER/CATHETER SET; T94C T94M T96M T98M

    Recall: Z-2940-2018 · Reported September 5, 2018

    Enforcement

    Recall Number
    Z-2940-2018
    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

    SOFT-LINE DUO-FLOW DOUBLE LUMEN CATHETER/CATHETER SET; T94C T94M T96M T98M

    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

    MCDA290 MHLQ370 MHMZ270 MHSN190 MHTH950 MHTR800 MHXL900 MJAT510 MJAZ020 MJBL200 MJCV760 MJFP340 MJGC620 MJGX680 MJKN210 MJLP090 MLDF860 MHLL060 MHND620 MHPA230 MHQZ510 MHSR590 MHXJ990 MHYS090 MJDW030 MJGK930 MJGX690 MJJF710 MLBA570 MLBK460 MLCT650 MHKJ180 MHMJ970 MHPK440 MHRN870 MJBP190 MJHJ860 MLBG870

    Distribution

    Nationwide distribution; worldwide distribution.

    Quantity

    N/A