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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 .
Contact Information 02 9490 6200 - Medical Industries