| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01596-1 |
| Product Name/Description |
Vinyl examination/treatment glove, non-powdered
Batch Numbers: 4-2015, 5-2015, 2-2016, 3-2016, 201401, 3-2015
ARTG Number: 218314 |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
16/12/2016 |
| Responsible Entity |
|
| Reason/Issue |
It has been found that Shantex Vinyl Examination Gloves have failed to demonstrate compliance with the standard (AS.1011:2014) and are not suitable for medical/ biological applications because they do not provide an effective barrier suitable for medical or biological protection. |
| Recall Action |
Recall |
| Recall Action Instructions |
Shantex is advising the distributor with affected stock to return them for credit. Retailers with affected stock are to return them to the distributor for credit.
This action has been closed out on 08/11/2018 |
| Contact Information |
07 3722 1161 - Shantex Medical Products |