| 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 |
|
| 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 |