FDA warns public against the use of an unregistered medical device

By Analou De Vera

The Food and Drug Administration (FDA) has warned the public against the use of an unregistered “medical device.”

Pure Aid Gauze Pads (SCREENSHOT / FDA)
Pure Aid Gauze Pads (SCREENSHOT / FDA)

The FDA said that on their post-marketing surveillance, they have verified that the product named Pure Aid Gauze Pads has not gone through the agency’s registration process.

“Accordingly, since this unregistered medical device have not gone through evaluation and testing process of the FDA, the agency cannot guarantee its quality and safety,” the FDA said.

The FDA said that the use of such “violative” may pose potential health hazards.

“In light of the above, the public is advised not to purchase the aforementioned violate product,” the FDA said.

“All concerned establishments and/or entities are warned not to distribute the above-identified violative medical device product until they have already been covered by appropriate authorization,” it added.

Meanwhile, the agency also advised the consumers to be vigilant against medical devices that might not be registered with the FDA.

“Always check if a medical device has been registered with the FDA before purchasing it by making use of the embedded Search feature of the FDA website,” the agency said.

 
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