| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00480-1 |
| Product Name/Description |
12 Instrument Sterilisation Tray (used for the Conquest Manual Instrument line)
Catalogue Number: 0242000012
All lots shipped from manufacturer between January 10, 2008 and January 10, 2014
ARTG Number: 140639 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
29/04/2014 |
| Responsible Entity |
|
| Reason/Issue |
Stryker has become aware that Gravity sterilisation parameters provided in the 12 Instrument Sterilisation reprocessing guide (1000400920 Rev D) did not fully consider all worst-case scenarios during validation testing. Although, to date there have been no reported events to Stryker of infection as a result of the use of the sterilization parameters previously provided with these trays, there is a remote possibility for infection. |
| Recall Action |
Recall for Product Correction |
| Recall Action Instructions |
End users are advised to discard any old Instructions for Use (IFU) for 12 Instrument Sterilization Tray(s) that make reference to the gravity steam sterilization method (121oC for 30 minutes). New IFU can be downloaded from www.stryker.com/12instrumenttray |
| Contact Information |
1800 803 601 - Stryker South Pacific |