| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-00208-1 |
| Product Name/Description |
Coban 2 Compression Layer (active support bandage)
Product Code: 20024
ID Number: DH888822474
Lot Number: 2018-12AQ
Expiry Date: Dec 2018
ARTG Number: 235181 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
24/02/2016 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer has advised that during printing an operator error occurred where the foil used as the primary packaging for Coban 2 shows "Coban 2 Lite" as the product name. The compression bandage, the outer carton packaging, the corresponding instructions for use as well as the colour coding (purple for Coban 2) are correct.
If Coban 2 is used (rather than Coban 2 Lite) for a patient requiring moderate compression, a reduced blood circulation in the extremity is a possible consequence. This could lead to local necrosis or complete ischemia of the lower leg. |
| Recall Action |
Recall |
| Recall Action Instructions |
3M Australia is advising users to inspect stock and quarantine the affected batch prior to returning to 3M.
This action has been closed out on 17/08/2018 |
| Contact Information |
02 9498 9180 - 3M Australia |