Adhesive Bandage, medical device consultant, FDA, CDSCO, ISO 13485

The Food and Drug Administration (FDA) has warned the public against an unregistered adhesive bandage being sold in the market.

“The FDA advises the general public and all healthcare professionals against the purchase and use of the unregistered medical devices: the Bang-Ze First Aid Fabric Dressing 70mm x 18mm,” the agency stated in its Advisory No. 2019-004.

The FDA said that its post-marketing surveillance have verified that the said product have not gone through the registration process of the agency and have not been issued with proper approval as Certificate of Product Registration.

“Accordingly, since these unregistered medical devices have not gone through evaluation and testing process of the FDA, the agency cannot guarantee its quality and safety. The utilization of such violative item may present potential wellbeing dangers to the devouring open,” the agency said.

“In light of the above, the public is advised not to purchase them and to be vigilant against medical device that might not be duly registered with FDA,” it added.

The FDA warned concerned establishments not to distribute the said product until it have already been covered by the appropriate authorization, “otherwise, regulatory actions and sanctions shall be strictly pursued.”

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