| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-00635-1 |
| Product Name/Description |
1322 3M Comply Lead Free Steam Indicator Tapes & 1355 3M Comply Lead Free Steam Indicator Tapes for Disposable Wraps
1322 3M Comply Lead Free Steam Indicator Tapes
Stock Numbers: CT060934651 & CT060934669
Roll Sizes: 1322-18MM & 1322-24MM (respectively)
1355 3M Comply Lead Free Steam Indicator Tapes for Disposable Wraps
Stock Numbers: CT060934693 & CT060934701
Roll Sizes: 1355-18MM & 1355-24MM (respectively)
Lot No: 2018-04RA, 2018-05RB, 2018-06RC & 2018-06RD
ARTG Number: 126363 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
19/05/2017 |
| Responsible Entity |
|
| Reason/Issue |
During a recent investigation, the manufacturer confirmed some rolls within the four (4) affected lots failed to meet the visual standard for colour development following exposure to steam sterilisation. If the product fails to meet the colour development standard it could be interpreted that the pack has not been exposed to an adequate sterilisation process. |
| Recall Action |
Recall |
| Recall Action Instructions |
3M Australia is requesting users to discontinue use of affected products and notify 3M to receive a refund or replacement. Distributors are requested to cease distribution of affected products and forward the recall notification to customers who have received the affected lots. Distributors are further requested to consolidate returned products from their customers with their own affected stock and notify 3M accordingly to receive a refund or replacement.
This action has been closed out on 18/02/2019 |
| Contact Information |
1300 363 878 - 3M Health Care Customer Help Line |