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L-Gel Ultrasound Transmission Gel recall

Product recall

16 August 2012

All lots of L-Gel Ultrasound Transmission Gel manufactured between June 2011 and May 2012 by Shanghai Shenfeng, China are being recalled. This gel is used during ultrasounds. The gel is supplied in 250ml and 5L bottles.

The recall has occurred after TGA tests found bacterial contamination in lot numbers 2011 06 17 to 2012 04 09 of L-Gel Ultrasound Transmission Gel.

This gel was sold in Australia to health professionals by a number of suppliers. All suppliers of this ultrasound gel have been contacted by the TGA and they are in the process of quarantining and recalling any affected stock.

Health professionals should stop using these products immediately and patients concerned about exposure to this product should seek advice from their GP.

Information for health professionals

Health professionals should not use L-Gel Ultrasound Transmission Gel products with these lot numbers. You may not be able to identify contaminated products by looking at the gel.

• Where possible identify patients who have been exposed to these lots of L-Gel Ultrasound Transmission Gel. Review the procedures they underwent and the outcomes of the procedures, and take further action as necessary.
• Do not use L-Gel Ultrasound Transmission Gel with lot numbers 2011 06 17 to 2012 04 09.
• Quarantine unopened product for return to the supplier when requested. Australian sponsors have been contacted by the TGA and are working with the TGA to recall affected products.
• Dispose of all opened containers by following your facility's procedure for disposing of bio-hazardous materials.
• Ensure reusable dispenser bottles are completely emptied, thoroughly washed and dried daily / weekly according to your facility's infection control practices.
• Clean all reusable equipment according to the manufacturer's instructions. 
• Do not reuse single use equipment.

Please ensure that for procedures that require the use of sterile gel, you use only unopened containers labelled 'sterile'.

Information for patients

There is a small risk that patients who have been exposed to contaminated L-Gel Ultrasound Transmission Gel may develop an infection, this infection will usually be in the area where the gel was used. If you are concerned about having been exposed to the contaminated gel, consult your GP, especially if you are showing signs of infection.

Ultrasonic gel is used when an ultrasound procedure is undertaken. Ultrasounds are used in many different medical situations including

• accident and emergency,
• chiropractic,
• diagnostic imaging,
• gastroenterology,
• obstetrics and gynaecology,
• physiotherapy, and
• urology.

About the bacterial contamination

The TGA has confirmed the presence of the bacteria Burkholderia cepacia, Stenotrophomonas maltophilia and Raoultella planticola in samples taken from the contaminated lots.

• Burkholderia (Psuedomonas) cepacia can be found in soil and water. B cepacia is spread by contamination of medicines and devices as well as from person-to-person contact and from contact with contaminated surfaces. Exposure to this organism is a low risk to healthy individuals however people with weakened immune systems or chronic lung diseases (particularly cystic fibrosis) are more susceptible to colonisation or infection. B cepacia has been known to cause skin and soft tissue infections, surgical wound infections, respiratory and genitor-urinary tract infections.
• Stenotrophomonas (Psuedomonas) maltophilia is found in water environments. As this organism can be found in water or fluids, respiratory secretions, urine, intravenous fluids and irrigation solutions as well as humidifier water, catheters and breathing tubes are susceptible to being contaminated. Infection usually only arises in people with weakened immune systems and those undergoing medical procedures. Healthy people with an intact immune system may become infected through wound contamination. This organism may also cause septicaemia, pneumonia, urinary tract infections, soft tissue infections, endocarditis, meningitis and eye infections.
• Raoultella (Klebsiella) planticolla is widespread in the environment. Clinical conditions caused by this organism include skin, soft tissue and wound infections. In addition this organism is reported as having caused cholecystitis, pancreatitis, pneumonia, and septic shock.

All of the above organisms may be very persistent in the environment; good hygiene and infection control practices are necessary to reduce the risk of transmission of these organisms to susceptible patients.

Specialist clinical advice should be sought regarding identification of colonisation or infection and any treatment needed.

Reporting problems

Consumers and health professionals are encouraged to report problems with medical devices. Please refer to the TGA Internet site for more information on the TGA Incident Reporting and Investigation Scheme (IRIS).

The TGA cannot give personal 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 medical device.

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