Events

Recall of Via2BagDirect Connect

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medimop Medical Projects Ltd..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    79243
  • Event Risk Class
    Class 2
  • Event Number
    Z-0972-2018
  • Event Initiated Date
    2017-10-06
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161741
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Set, i.V. Fluid transfer - Product Code LHI
  • 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.
  • Action
    The recalling firm's sent an Urgent Medical Device Recall Letter dated October 13, 2017. was supplied to the consignee which contains the instructions for the recall process to the consignee. The notification letter will be sent to the Distributor via email. The notification letter instructs the distributor to notify the Customer/Users via the Medimop consignee recall letter. For further questions, please call (610) 594-4353.

Device

Via2BagDirect Connect
  • Model / Serial
    Lots: 9507,9508,9509,9510,9511,9512,9513.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution
  • Product 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.
  • Manufacturer
    Medimop Medical Projects Ltd.

Manufacturer

Medimop Medical Projects Ltd.
  • Manufacturer Address
    Medimop Medical Projects Ltd., 4 Hayetzira Street,, P.O. Box 2499, Raanana Israel
  • Source
    USFDA