| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00116-1 |
| Product Name/Description |
Futuro Quick Strap Ankle Support
Product Code: 47736EN
3M Code: 70005091510
All Batch/Lot Numbers
ARTG Number: 214679
(3M Australia Pty Ltd - Orthosis, leg, ankle/foot, unit) |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
19/02/2018 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer is aware that there is natural rubber latex (1%) in the Futuro Quick Strap Ankle Support. Currently packaging of this product does not have an explicit caution statement in relation to latex.
The existing caution statement available on this product is "caution: Some individuals may be sensitive to neoprene or neoprene blend rubber. If a rash develops, discontinue use and consult a physician".
Individuals that are sensitive to latex may develop an allergic reaction.
No alleged medical complaints regarding this product have been received in Australia during its period of distribution.
This recall does not affect any other 3M products. |
| Recall Action |
Recall |
| Recall Action Instructions |
3M is advising pharmacies to quarantine affected stock and return it to the distributor.
3M will arrange collection of affected devices from distributors.
This action has been closed out on the 26/11/2018. |
| Contact Information |
1300 363 878 - Customer Service Support |