BEUDAMED
    FDA Enforcement Class II Terminated

    Vial2BagDC, Product Number 6070112. The 20mm Vial2Bag DC device, is intended for use in healthcare facilities or in-home environment by the patient or care-giver to aid and support prescribed treatment and therapy. The device consists of the Vial2Bag piercing spike and cover, the IV Port connector and an integrated Vial Adapter (20mm) for access to the drug/solution vial.

    Recall: Z-0972-2018 · Reported March 21, 2018

    Enforcement

    Recall Number
    Z-0972-2018
    Event ID
    79243
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medimop Medical Projects Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    March 21, 2018
    Initiation Date
    October 6, 2017
    Classification Date
    March 12, 2018
    Termination Date
    January 23, 2024
    Address
    4 Hayetzira Street,, P.O. Box 2499, Raanana, N/A, Israel

    Description

    Vial2BagDC, Product Number 6070112. The 20mm Vial2Bag DC device, is intended for use in healthcare facilities or in-home environment by the patient or care-giver to aid and support prescribed treatment and therapy. The device consists of the Vial2Bag piercing spike and cover, the IV Port connector and an integrated Vial Adapter (20mm) for access to the drug/solution vial.

    Reason

    Medimop is recalling certain lots of this product Vial2Bag DC due to the potential of the IV Port separating from the Via12Bag DC body during the drug reconstitution I IV Set attachment process.

    Code Info

    Lots: 9507,9508,9509,9510,9511,9512,9513.

    Distribution

    US Distribution

    Quantity

    453,600 units