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Type of Product Medical Device
TGA Recall Reference RC-2016-RN-00251-1
Product Name/Description STERIS Quick Connects (used with the Steris System 1 Express and System 1 Plus sterilisers)

Product Codes: ST-QKC1736INT and ST-QKC-1737INT

ARTG Number: 113489
Recall Action Level Hospital
Recall Action Classification Class III
Recall Action Commencement Date 4/03/2016
Responsible Entity Device Technologies Australia Pty Ltd
Reason/Issue Quick Connects provide directed flow of sterilant use dilution and rinse water into the internal lumens of specifically identified endoscopes to achieve liquid chemical sterilisation.
STERIS has learned that one of the hysteroscope models (Karl Storz 11264BBU1) listed for processing in STQKC1736INT and ST-QKC-1737INT has one inlet port rather than two inlet ports as indicated in the Quick Connect processing instructions. A user who connects the Karl Storz 11264BBU1 hysteroscope according to the processing instructions will observe an unused Quick Connect port adapter. STERIS performed testing on the Karl Storz 11264BBU1 hysteroscope which confirmed that despite this unused port adapter, the flow provided to the lumen is more than adequate. Therefore, the efficacy of the liquid chemical sterilisation process is not affected. However, there is potential for user confusion due to the unused Quick Connect port adaptor if used for this hysteroscope.
Recall Action Recall for Product Correction
Recall Action Instructions Device Technologies is advising users that updated labelling kits and instructions for use will be provided. The impacted hysteroscope can be processed using the ST-QKC-1705INT processing manual. This action has been closed-out on 30/01/2017.
Contact Information 02 8244 3721 - Device Technologies