China NMPA Product Recall - Ultrasonic atomizer

Nanning Sanke Medical Device Co., Ltd. initiated a voluntary Class 3 recall of its ultrasonic nebulizers, as announced by the National Medical Products Administration (NMPA) on August 8, 2017. The primary reason for this action was the discovery of insufficient labeling on the product. Specifically, the labels lacked clear markings indicating the necessary power connection conditions for safe and proper use of the device. This recall falls under the oversight of regulatory bodies such as the NMPA, which issues product recall notifications to ensure medical device safety and compliance within the market. The company's decision to voluntarily recall the affected products, identified by Registration No.: Gui Food and Drug Administration Medical Device (20142230058), demonstrates its commitment to addressing regulatory deficiencies. A Level 3 recall, as designated by the NMPA, typically indicates a situation where the use of, or exposure to, a violative product is not likely to cause adverse health consequences. Nanning Sanke Medical Device Co., Ltd. provided further details regarding the specific models, specifications, and batch numbers of the affected ultrasonic nebulizers in a "Medical Device Recall Event Report Form" and an accompanying "Product Recall Notice." These documents were made available to facilitate the recall process and inform stakeholders. The company's proactive measure aims to rectify the labeling oversight and ensure that all product information is complete and accurate, thereby maintaining user safety and adherence to medical device regulations.