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Type of Product	Medical Device
TGA Recall Reference	RC-2012-RN-00792-3
Product Name/Description	L-Gell Ultrasound Transmission Gel – 5ltr & 250mls Catalogue number: LG5000 & LG250 All Batch numbers ARTG Number: 196931
Recall Action Level	Retail
Recall Action Classification	Class II
Recall Action Commencement Date	10/08/2012
Responsible Entity	Alpine Medical Pty Ltd T/A Medical Industries Australia
Reason/Issue	TGA's microbial testing of L-Gel Ultrasound Transmission Ge shows general microbial count exceeding the microbial standards for medicines (TGO 77) that are intended for cutaneous and mucosal use. Such microbial levels constitute a moderate to serious health hazard for infection, especially if the Ultrasound Transmission Gel is used for a non-intended purpose, e.g. an invasive procedure.
Recall Action	Recall
Recall Action Instructions	Customers to remove stock from use and contact the sponsor to arrange return of product. For more details, please see http://www.tga.gov.au/safety/alerts-device-l-gel-120816.htm .
Contact Information	02 9490 6200 - Medical Industries