L-Gel Ultrasound Transmission Gel 의 안전성 경고

Safety alert

2012-08-17

2012-08-17

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20120817.html

Medical device safety alert: shanghai shenfeng l-gel ultrasound transmission gel the australia therapeutic goods administration (tga) has issued a recall of all lots of l-gel ultrasound transmission gel manufactured between june 2011 and may 2012 by shanghai shenfeng, china. the gel is supplied in 250ml and 5l bottles. the recall was initiated after tga tests found bacterial contamination (burkholderia cepacia, stenotrophomonas maltophilia and raoultella planticolla) in lot numbers 2011 06 17 to 2012 04 09 of the product. 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. stop using l-gel ultrasound transmission gel products with lot numbers 2011 06 17 to 2012 04 09. 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. for details, please refer to tga website: http://www.Tga.Gov.Au/safety/alerts-device-l-gel-120816.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 17 august 2012.