THE Food and Drug Administration (FDA) yesterday warned the public against the presence of an unnotified medical device product used to measure blood pressure.
In its Advisory No. 2024-0527, the FDA advised the public against purchasing and using the “Wilcare Aneroid Sphygmomanometer with Stethoscope.”
“The FDA verified through post-marketing surveillance that the above-mentioned medical device product is not notified and no corresponding Product Notification Certificate has been issued,” said the FDA.
“FDA warns all healthcare professionals and the general public not to purchase and use the unnotified medical device product,” it added.
The agency said using the product may pose a danger as the unnotified medical device has not gone through the evaluation process of the FDA.
“The agency cannot assure its quality and safety,” the FDA said as it issued a similar warning to all concerned establishments for them not to distribute, advertise, or sell the said medical device product.
