Print version of this report
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 3M Australia Pty Ltd
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