| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00298-1 |
| Product Name/Description |
STERRAD 100NX and STERRAD 200 Sterilisation Systems
Product Code: 10104 & 10200
All units shipped to date
ARTG Number: 123603 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
4/04/2013 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer (ASP) has determined that these systems may emit an odour or smell into the surrounding environment that is not typical to normal operating conditions. Although odours/ smells occur environmentally throughout the healthcare environment, odours/smells may also be related to normal breakdown of the oil used in the steriliser vacuum pump on the STERRAD 100NX and/or STERRAD 200. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
The manufacturer is providing users with work around instructions while it continues to investigate the root cause of the problem. |
| Contact Information |
1800 252 194 - Johnson & Johnson Medical Customer Service |