| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00320-1 |
| Product Name/Description |
EVOTECH Endoscope Cleaner and Reprocessor (ECR) System (Endoscope disinfecting unit)
Product code: 50004
All lot/serial numbers affected.
ARTG number: 146438 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
12/04/2013 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer has determined that under certain circumstances the EVOTECH Endoscope Cleaner and Reprocessor System may not properly calculate the expiration date of the CIDEZYME XTRA Multi Enzymatic Detergent from the information entered by the user. In these circumstances, the expiration date displayed on the EVOTECH ECR screen is one month after the labelled expiration date. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Johnson & Johnson is providing instructions on how to identify if there is any discrepancy between the calculated expiration date and the labelled expiration date. Users are advised to adhere to the labelled expiration date. |
| Contact Information |
1800 252 194 - Johnson & Johnson Medical Customer Service |