| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00631-1 |
| Product Name/Description |
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
ARTG Number: 278197 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
12/05/2017 |
| Responsible Entity |
|
| Reason/Issue |
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. |
| Recall Action |
Recall |
| Recall Action Instructions |
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 .
This action has been closed out on the 26/09/2018. |
| Contact Information |
08 6162 9911 - Meditech Systems Asia Pacific |