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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 Stryker Australia Pty Ltd
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
Contact Information 1800 803 601 - Stryker South Pacific