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Type of Product	Medical Device
TGA Recall Reference	RC-2013-RN-01237-1
Product Name/Description	Inflation bulbs used with Safescope Sigmoidoscopes Product Code: SCU-SS220 Batch Number: 061326 ARTG Number: 165977
Recall Action Level	Hospital
Recall Action Classification	Class III
Recall Action Commencement Date	9/12/2013
Responsible Entity	Med-Chem Surgical Pty Ltd
Reason/Issue	Med Chem is recalling affected bulbs following reports of inflation bulbs not compressing. After physical inspections of the fault by both Logikal Health and its supplier, it has been determined that this fault is due to a misshaped component within the valve located on the tubing which extends from the bellows.
Recall Action	Recall for Product Correction
Recall Action Instructions	Med Chem Surgical is requesting their customers to test any remaining product from the affected batch by applying slight pressure through the packaging. Any bulbs that fail to compress must be returned immediately.
Contact Information	02 9699 6460 - Med-Chem Surgical Pty Ltd