BEUDAMED
    FDA Enforcement Class I Terminated

    Vial2BAG DC 13mm, REF 6070111, Single use only, Rx Only

    Recall: Z-0767-2019 · Reported February 6, 2019

    Enforcement

    Recall Number
    Z-0767-2019
    Event ID
    81877
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    WEST PHARMA. SERVICES IL, LTD
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 6, 2019
    Initiation Date
    December 26, 2018
    Classification Date
    January 28, 2019
    Termination Date
    July 20, 2022
    Address
    4, Ha-Sheizaf, N/A, Ra'Anana, N/A, N/A, Israel

    Description

    Vial2BAG DC 13mm, REF 6070111, Single use only, Rx Only

    Reason

    Adverse events have been reported with the use of oxytocin in conjunction with the product in pregnant women. There is a possibility that the device may cause inadequate admixing of drug with the solution in the IV bag. This could lead to concentrated drug pooling in the device and bolus injections.

    Code Info

    UDI: (01)07290108240061(17)211031(10)A839(90)3609812 5(91)6070111 Lot Numbers: 7153, 7154, 7634, 7688, 7752, 7909, 7955, 8152, 8153, 8154, 8232, 8233, 8234, 8235, 9028, 9175, 9029, 9176, 9177, 9178, 9367, 9368, 9369, 9370, 9654, 9656, 9655, 9918, 9710, 9711, 9712, 9713, 9839, 9840, 9983, 9984, 9992, 9993, 9994, 9995, A123, A124, A790, A805, A806, A791, A792, A793, A794, A795, A796, A797, A807, A808, A809, A810, A834, A835, A836, A837, A838 & A839

    Distribution

    US Distributor in MO

    Quantity

    3.9 million units