KUALA LUMPUR – The Medical Device Authority (MDA) has issued a recall for MyMedic brand ultrasound gel, batch number USG402-2306, to MyMedic Innovation Sdn Bhd.
MDA chief executive Muralitharan Paramasua said that a safety risk was identified due to the gel being contaminated with Burkholderia cepacia complex (BCC).
“The source of the BCC contamination is unknown, and the company has conducted a thorough investigation to determine the cause and has taken all necessary corrective measures,” he said in a statement today.
Muralitharan mentioned that the contamination could lead to serious infections, particularly when the gel comes into contact with open wounds, skin abrasions, or mucous membranes. This poses a high risk to users with weakened immune systems or chronic conditions.
Following the recall order, Muralitharan advised all users to cease using the affected batch and return the product to the company for disposal.
He added that a notification had been issued by the company to all affected users through a recall notice.
For any inquiries or further information, users can contact MDA officers via the link https://femes.mda.gov.my/. – July 23, 2024