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Type of Product Medical Device
TGA Recall Reference RC-2012-RN-00697-3
Product Name/Description STERRAD 100S System Cassettes (To provide the hydrogen peroxide sterilant used in the STERRAD Steriliser)

Product Number: 10113

Lot Number: 12A070

ARTG Number: 123602
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 11/07/2012
Responsible Entity Johnson & Johnson Medical Pty Ltd
Reason/Issue The manufacturer has discovered that printed information on the cassette results in the steriliser being unable to properly read the barcode. During the automated process used to print information on STERRAD 100S System cassettes, an additional thirteenth (13th) bar was added to the barcode resulting in an unusable cassette. Because the STERRAD 100S System is designed to accept only properly coded cassettes, the STERRAD 100S will reject all incorrect cassettes and display an error message: “INCORRECT CASSETTE TYPE”.
Recall Action Recall
Recall Action Instructions Quarantine and return affected product to Johnson & Johnson Medical.
Contact Information 1800 252 194 - JJM Customer Service