| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2013-RN-00301-1 |
| Product Name/Description |
Stryker Suction Irrigation Tips (general purpose irrigation/aspiration units)
Multiple product codes and lot numbers
ARTG Number: 142830 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
4/04/2013 |
| Responsible Entity |
|
| Reason/Issue |
The pre-vacuum steam sterilisation temperature in the Instructions for Use (IFU Part # 1000-400-100 Rev. K) is incorrectly listed as 121 - 123 degrees centigrade, instead of the correct 132 - 133 degrees centigrade (IFU Part # 1000-400-100 Rev. L). |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
Stryker is correcting the Instructions For Use. |
| Contact Information |
02 9467 1214 - Stryker Regulatory Affairs |