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 |
|
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 |