| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00207-1 |
| Product Name/Description |
Coban 2 Lite Compression Layer (active support bandage)
Product Code: 20724
ID Number: DH888822441
Lot Number: 2017-21AP
Expiry Date: Dec 2017
ARTG Number: 235181 |
| Recall Action Level |
Retail |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
24/02/2016 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer has identified that during printing an operator error occurred where the foil used as the primary packaging for Coban 2 Lite shows "Coban 2" as the product name. The compression bandage, the outer carton packaging, the corresponding instructions for use as well as the colour coding (green for Coban 2 Lite) is correct.
If Coban 2 Lite is used by mistake for a patient requiring regular compression, the compression efficacy might not be sufficient. This would be noticed by the health care provider and corrected with the next bandage change. |
| Recall Action |
Recall |
| Recall Action Instructions |
3M Australia is advising users to inspect stock and quarantine any affected product for return or credit.
This action has been closed-out on 30/01/2017. |
| Contact Information |
02 9498 9180 - 3M Australia |