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Type of Product Medical Device
TGA Recall Reference RC-2013-RN-00781-1
Product Name/Description Medtronic Xomed Instrument Trays

Lot Numbers: All lots distributed prior to July 2013

Multiple Product Numbers
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 1/08/2013
Responsible Entity Medtronic Australasia Pty Ltd
Reason/Issue During the validation of a new instrument, testing revealed that use of a GRAVITY steam cycle with one of the listed instrument trays did not produce the Sterility Assurance Level (SAL) of 10-6 required by industry standard (ANSI/AAMI ST77:2006). A subsequent investigation of all Medtronic Xomed instrument trays identified additional trays as having certain locations within the tray that would not meet the recommended sterilization level of SAL 10-6 during GRAVITY steam sterilization cycles.
Recall Action Recall
Recall Action Instructions Hospitals that use GRAVITY steam sterilisation cycles are requested to quarantine all stock immediately. Hospitals that use PREVACUUM steam sterilisation are advised that they can continue to use the trays once they have attached a label stating 'PREVACUUM ONLY' provided by Medtronic.

A Medtronic representative will be in contact with customers to arrange for replacement with a new tray with updated labelling.
Contact Information 02 9857 9000 - Medtronic Australasia