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Type of Product	Medical Device
TGA Recall Reference	RC-2013-RN-01355-1
Product Name/Description	STERRAD 100S, STERRAD 50 and STERRAD NX Sterilisation Systems ARTG Number: 123603
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	23/12/2013
Responsible Entity	Johnson & Johnson Medical Pty Ltd
Reason/Issue	ASP has received customer complaints by healthcare workers reporting odours/smells potentially emanating from the STERRAD Systems. Odours/smells may also be related to normal breakdown of the oil used in the steriliser vacuum pump on the STERRAD 100S ,STERRAD 50 and/or STERRAD NX . The reported odours/smells do not impact sterility of the devices processed within the STERRAD Systems. ASP is investigating this issue to determine the source of the odour/smell and will continue to perform Planned Maintenance in accordance with each system’s schedule.
Recall Action	Recall for Product Correction
Recall Action Instructions	If users observe any odours/smells, Johnson and Johnson Medical is requesting them to leave the room as a precaution and discontinue the use of STERRAD Systems until they are serviced.
Contact Information	1800 252 194 - Johnson & Johnson Medical Representative