FDA lists 'risky' medical devices requiring caution
The Food and Drug Administration (FDA) has issued a strong advisory to the public, alerting them to the risks associated with purchasing and using nine medical device products that have not undergone the agency's rigorous evaluation process.
As of Sept. 18, the FDA has identified seven “unnotified” and two “unregistered” medical device products, declaring them unsafe for use.
The FDA has taken precautions to protect public health by strongly warning against the purchase or use of certain unnotified products.
Among the flagged unnotified medical device products are “TRANS-GEL® ULTRASOUND TRANSMISSION GEL,” “SURGITECH HOT/COLD PACK, MICROWAVEABLE-REUSABLE,” “WILCARE DIAGNOSTIC LAMP,” “RX DR. CARE™ ICE BAG RUBBERIZED,” “BIO+ NITRILE POWDER FREE DISPOSABLE GLOVES,” “WELLCARE KINESIOLOGY MUSCLE TAPE,” and “RX DR. CARE EXAMINATION GLOVES VINYL GLOVES POWDER-FREE.”
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.
The FDA also stated that all concerned establishments are strongly cautioned against distributing, advertising, or selling these violative medical device products.
Moreover, the FDA has also advised against the purchase and use of "unregistered" medical device products, including "MEDX ALL-SILICONE DUODENAL TUBE FR18" and "AGUAWATER ALKALINE WATER PURIFIER."
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. (Zekinah Elize Espina)