| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00578-1 |
| Product Name/Description |
Sonopet Console (Ultrasonic Surgical Aspirator System)
Catalogue number: 5450852000
Serial numbers: 1134000114, 1134000124, 1134000134, 1134000144, 1134000184, 1134000204 & 1209400174
ARTG number: 174364 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
6/06/2013 |
| Responsible Entity |
|
| Reason/Issue |
Stryker has received reports that the Irrigation Pump may not function and audible alarm may not sound. In cases where the irrigation pump fails, saline would not be provided to the tip and the tip may overheat. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Stryker will be replacing affected units with a loan unit until the unit is repaired. |
| Contact Information |
1800 803 601 - Stryker Regulatory Affairs and Quality Assurance Coordinator |