Events

Recall of Device Recall TEVADAPTOR

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Migada Inc..

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
    51421
  • Event Risk Class
    Class 2
  • Event Number
    Z-1244-2009
  • Event Initiated Date
    2008-12-18
  • Event Date Posted
    2009-05-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-07-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=80247
  • 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
    I.V. Fluid Transfer Set - Product Code LHI
  • Reason
    Syringe adaptor is disintegrating when attached to the end of the syringe.
  • Action
    A Field Safety Notice, dated 12/8/2008, was sent to all TEVADAPTOR customers advising them not to use drugs containing N,N-Dimethylacetamide. Teva Medical is presently revising the instruction leaflet supplied with each TEVADAPTOR to include a warning against the use of drugs containing N,N-Dimethylacetamide. Teva Medical will introduce this revised leaflet to current production as soon as practicable. In the meantime, Teva Medical will advise all users of the potential problem by means of the Urgent Field Safety Notice. Customers are to ensure that the safety notice is passed to all those who need to be aware within their organizations. Questions should be directed to their local contacts at B Braun, USA.

Device

Device Recall TEVADAPTOR
  • Model / Serial
    all lots
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    TEVADAPTOR Closed Drug Reconstitution and Transfer System, a closed system used to prepare drugs, including cytotoxic drugs, for intravenous infusion or injection. Model number is MG412110. The device is a single use device.
  • Manufacturer
    Migada Inc.

Manufacturer

Migada Inc.
  • Manufacturer Address
    Migada Inc., P.O Box 888, Kiryat Shmona Israel
  • Source
    USFDA