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DJO Global Pty Ltd is recalling all batches of CHATTANOOGA brand ultrasound products because of the risk of contamination with a bacteria, Burkholderia cepacia complex (Bcc).
The affected products include CONDUCTOR Transmission Gel, Myossage, and Ultra-Myossage lotions (ARTG 169757).
Most of these products have been supplied individually but in some instances they are a sample inside a kit.
The affected products have a three year shelf life and have been supplied up until August 2021.
What should I do?
You must immediately stop using and discard all units of these products.
Check if you received the gel/lotion as part of an 'Intelect' kit. The complete list of affected kits is under Further Information below.
You must
- discard the gel/lotion sample
- completely clean and appropriately disinfect any ultrasound and warming devices that may have had contact with the product.
Once disinfected, the rest of the kit can continue to be used.
If you are a direct customer of DJO Global Pty Ltd, they will contact you with further instructions about the recall and replacement.
What is Burkholderia cepacia complex (Bcc) and what are the risks?
Burkholderia cepacia (Bcc) are bacteria commonly found in soil and water and pose little medical risk to healthy people. The use of contaminated ultrasound gel on intact skin, or for non-invasive procedures, poses only a low risk of infection.
There is a serious risk to certain vulnerable people. In those with weakened immune systems or chronic lung diseases, the bacteria can cause bloodstream infections with serious complications or result in death. Bcc is often resistant to antibiotics and is a cause of infection in hospitalised patients.
To date, DJO Global is not aware of any infections related to use of their products by Australian consumers or patients.
Further information
If you have any concerns or questions about this issue, contact DJO Global Customer Service on 1300 667 730.
The following kits may contain a sample of the affected products:
- Intelect RPW Unit (230v)
- Intelect RPW 2
- Intelect Mobile Ultrasound
- Intelect Mobile Combo
- Intelect ADV Mono Combo
- Intelect ADV Colour Combo w/ EMG
- Intelect Mobile 2 Ultrasound Kit EU plug
- Intelect Mobile 2 Ultrasound
- Intelect Mobile 2 Combo Kit EU plug
- Intelect Mobile 2 Combo
Reporting problems
Consumers and health professionals are encouraged to report any problems or side effects with therapeutic goods. Your report will contribute to the TGA's monitoring of these products.
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a therapeutic good.