| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01217-1 |
| Product Name/Description |
STERRAD Boosters and Adaptors (used in STERRAD NX steriliser and contains hydrogen peroxide sterilant)
ARTG Number: 123602 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
15/11/2013 |
| Responsible Entity |
|
| Reason/Issue |
It has been determined that the instructions for use (IFU) for the STERRAD Booster and STERRAD Adaptor include incorrect directions for when a STERRAD Booster and Adapter I, II and III is required to be used. It has also been determined that the current procedures for fitting a STERRAD Booster do not adequately mitigate the risk of improper seal between the scope and the booster or inadequate cleaning of the Adaptor/scope interface. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
J&J Medical is advising customers of the correct procedure to follow and providing the updated instructions for use (IFU) to ensure the devices are properly sterilised. A new checklist has also been developed to provide additional verification of the proper use of the STERRAD booster/adapter before and after the STERRAD cycle. This action has been closed-out on 10/02/2016. |
| Contact Information |
1800 252 194 - Johnson & Johnson Medical Customer Service |