Recall of Ultrasound Probe Cover (Telescopic folded with gel); and All Products labelled Meditech and Manufactured by: Yafho Bio-Technology Co Ltd; and/or Linmed Medical Co Ltd.

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Meditech Systems Asia Pacific Pty 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
    RC-2017-RN-00631-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2017-05-12
  • Event Country
  • Event Source
    DHTGA
  • Event Source URL
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    Meditech systems asia pacific has become aware that the product ultrasound probe cover (telescopic folded with gel) may be contaminated with burkholderia cenocepacia. whilst no other batches or pack sizes of this product have been supplied by meditech, users are further advised that all products labelled meditech and manufactured by: yafho bio-technology co ltd; and/or linmed medical co ltd.Are also affected by this recall.
  • Action
    All product labelled Meditech and Manufactured by Yafho Bio-Technology Co Ltd and/or Linmed Medical Co Ltd, including all stock of UltraSound Probe Cover (Telescopic folded with gel), is being quarantined immediately and Recalled from the Market. For further information please see https://www.tga.gov.au/alert/meditech-ultrasound-gel .

Device

  • Model / Serial
    Ultrasound Probe Cover (Telescopic folded with gel); andAll Products labelled Meditech and Manufactured by: Yafho Bio-Technology Co Ltd; and/or Linmed Medical Co Ltd.Part Number/ Order Code: 88654012Lot Number: 201701ARTG Number: 278197
  • Manufacturer

Manufacturer