| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-01264-1 |
| Product Name/Description |
Stryker Laparoscopic Manual Instruments and Accessories
Multiple item numbers/ product descriptions
All lots
ARTG Numbers: 145845, 228398, 141250, 142780, 228395 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
4/12/2014 |
| Responsible Entity |
|
| Reason/Issue |
Stryker has identified that unacceptable validation reports were in place to support the unwrapped 10 minute, 132° (270°F) gravity steam sterilization cycle as well as the Ethylene Oxide (EO) sterilization cycle listed in instructions for use. This may give rise to cross infection as viable bacteria/ pathogens could be delivered to the subsequent patient. As a result the Instructions for Use (IFU) are being modified in a manner that these two sterilisation methods are being deleted and the remaining two options currently given (Gravity Wrapped & Pre-Vacuum Wrapped methods) will remain in place. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
The Gravity Unwrapped sterilization cycle and the Ethylene Oxide sterilization cycle have both been deleted as sterilisation options from the Instructions for Use (IFU1000-401-070), for Laparoscopic Instruments and Accessories. New instructions for use reflecting this deletion will be circulated to customers.The Gravity Wrapped and Pre-Vacuum Wrapped sterilisation methods will remain unchanged. This ation has been closed-out on 06/07/2016. |
| Contact Information |
1800 803 601 - Stryker South Pacific |