| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-01242-1 |
| Product Name/Description |
STERRAD 100NX (Gas Plasma Steriliser)
Product Number: 10104-002
Affected Serial Numbers: 1042130065, 1042130028, 1042130024, 1042130067, 1042130002, 1042130063, 1042130064
ARTG Number: 123603 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class III |
| Recall Action Commencement Date |
22/11/2013 |
| Responsible Entity |
|
| Reason/Issue |
The manufacturer, ASP has determined that welds could loosen on the frame of STERRAD 100NX sterilizers manufactured between October 2012 and June 2013. These welds are used to secure support rails to the top tray assembly for added rigidity. The failure of the broken weld could potentially cause the chassis to deflect concaving downward. This failure does not impact the STERRAD 100NX sterilizer components performance. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
A JJM Field Service Engineer will install rivets and brackets to ensure the support rail brackets are firmly attached to the chassis to prevent possible separation. |
| Contact Information |
1800 252 194 - Customer Service |