The Therapeutic Goods Administration (TGA) of Australia has issued a medical device safety alert concerning 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. [Part number/ Order code: 88654012; Lot number: 201701].
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.
Users are advised that 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) should quarantined immediately and recalled from the market.
For details, please refer to the TGA websites:
http://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2017-RN-00631-1
https://www.tga.gov.au/alert/meditech-ultrasound-gel
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 16 May 2017