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Manila Bulletin devider Philippines devider National devider FDA issues warning against 'unnotified' medical devices, declares 4 products unsafe for use

FDA issues warning against 'unnotified' medical devices, declares 4 products unsafe for use

Published Jan 19, 2024 07:42 am

The Food and Drug Administration (FDA) issued a strong advisory to the public on Friday, Jan. 19, alerting individuals to the risks associated with purchasing and using “four” medical device products that have not undergone the agency's rigorous evaluation process.

FDA-Advisory-No.2024-0029.png
Photo from FDA website

Among the flagged unnotified medical device products are "Elderjoy Adult Slim Pants," "Adhesive Wound Dressing-Adhesive Island Dressing With Non-Adhering Pad," "5m Waterproof Medical Tape Anti-Allergic Pu Film Gauze Pad Transparent Fixation Tape Health Care," and "Fever Aid For Kids."

The FDA has taken precautions to protect public health by strongly warning against the purchase or use of certain unnotified products.

Post-marketing surveillance has confirmed that these medical device products lack the necessary notification, and no corresponding Product Notification Certificate has been issued, as per the FDA.

FDA-Advisory-No.2024-0033.png
Photo from FDA website

The agency also noted that all concerned establishments are strongly cautioned against distributing, advertising, or selling these violative medical device products.

Consumers were strongly urged to procure drug items exclusively from FDA-licensed facilities to ensure safety and efficacy.

Failure to comply may result in regulatory actions and sanctions, the FDA said.

FDA-Advisory-No.2024-0031.png
Photo from FDA website

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