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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