| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2017-RN-01395-1 |
| Product Name/Description |
V-PRO 60 Low Temperature Sterilisation System with VAPROX HC Sterilant
Distributed between 31 July 2014 and 17 August 2017
ARTG Number: 154905 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
7/11/2017 |
| Responsible Entity |
|
| Reason/Issue |
Device Technologies has identified a software issue where the V-PRO 60 software verifies expiration date of the VAPROX Sterilant upon completion of the sterilisation cycle rather than prior to cycle initiation. Verification of the VAPROX expiration date at the end of the sterilisation cycle will allow for the completion of one cycle with expired VAPROX Sterilant. To date, the manufacturer Steris has not received any reports of adverse events related to this issue. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Device Technologies is advising users that microbial efficacy studies support a safety margin for use of the product for three days after the indicated expiry date. Users are advised to ensure the cycle printout indicates the expiration date of the Sterilant upon the completion of each cycle and change the sterilant if required. Instruments processed in a cycle with sterilant more than three days beyond its expiry date are not considered properly sterilised and should be reprocessed with a new cup of sterilant before use.
Device Technologies will be performing a software update as a permanent correction.
This action has been closed out on 7/09/2018. |
| Contact Information |
02 8244 3721 - Device Technologies |