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Type of Product	Medical Device
TGA Recall Reference	RC-2012-RN-00673-3
Product Name/Description	STERRAD CYCLESURE 24 Biological Indicators within Validation Kits - Product codes: 14324, 20253, 20228, 20232 (sterilisation process indicator) Biological Indicators within Validation Kits: STERRAD NX Validation Kit – Product code 20253 STERRAD 100NX Validation Kit – Product code 20228 STERRAD 100S/50 Validation Kit – Product code 20232 Multiple lot numbers ARTG number: 134121
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	5/07/2012
Responsible Entity	Johnson & Johnson Medical Pty Ltd
Reason/Issue	The manufacturer, ASP, has determined that it does not have adequate data to support the entire duration of the product’s labelled shelf-life. As a result, the shelf life of STERRAD CYCLESURE 24 Biological Indicator (BI) will be reduced by 9 months from the current expiry date on the product label.
Recall Action	Recall
Recall Action Instructions	J&J is asking customers to quarantine the affected lots that exceed the newly determined expiration date and return it to J&J. Until the replacement stock is available, customers may continue to use the current inventory if it still has more than 9 month’s shelf life remaining. Product with labelled expiry date of May 2013 or later can be used.
Contact Information	1800 252 194 - Johnson & Johnson Medical