| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2015-RN-00432-1 |
| Product Name/Description |
EVOTECH Endoscope Cleaner and Reprocessor (ECR)
Part numbers: 50004 and 50004-002
ARTG number: 146438 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
22/05/2015 |
| Responsible Entity |
|
| Reason/Issue |
The EVOTECH Endoscope Cleaner and Reprocessor (ECR) may not detect an improper endoscope connection on two channels, and subsequently pass the cycle without cancellation if there is a disconnected scope. The likelihood of this occurrence is low, and ASP has not received complaints or reports of adverse events related to this issue.
The EVOTECH ECR is designed to verify endoscope connections for each cycle. If an improper connection is detected, the system is designed to stop and cancel the cycle. This system detection, along with a user verification step stated in the User’s Guide to verify the connections of the endoscope channels before and after the completion of a cycle, help to ensure that an endoscope has been processed properly.
As a result sites may need to manually process endoscopes which may increase processing time. An accumulation of processing time may result in surgical delay or rescheduling patients. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
A workaround is provided via the Customer Letter whilst a permanent fix is developed. This action has been closed-out on 03/03/2016. |
| Contact Information |
1800 252 194 - Johnson & Johnson Medical Customer Service |