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Type of Product	Medical Device
TGA Recall Reference	RC-2016-RN-00238-1
Product Name/Description	Pentax ED-3490TK Video Duodenoscope ARTG Number: 194533
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	7/04/2016
Responsible Entity	Hoya Lens Australia Pty Ltd
Reason/Issue	Pentax is issuing updated, validated manual reprocessing instructions for the ED-3490TK Video Duodenoscope to replace those provided in the original device labelling. The updated reprocessing instructions for the ED-3490TK Video Duodenoscope include a more rigorous protocol for pre-cleaning, manual cleaning, high-level disinfection and liquid chemical sterilisation procedures. In addition, updated instructions include additional text, figures, cautions and warnings intended to clarify the validated reprocessing procedure. If not properly reprocessed, residual body fluids and organic debris may remain in microscopic crevices of the device following an attempted cleaning and high level disinfection.
Recall Action	Recall for Product Correction
Recall Action Instructions	Pentax is providing affected customers with updated Instructions for Use intended to clarify the validated reprocessing procedure. This action has been closed-out on 27/01/2017.
Contact Information	03 9390 6838 - Pentax Medical