China NMPA Product Recall - Disposable sterile medical masks

Henan Kelong Medical Device Co., Ltd. initiated a voluntary Level III recall of its disposable sterile medical masks due to non-compliance with bacterial filtration efficiency regulations. The issue was identified through sampling and inspection by the Henan Provincial Drug Administration, with findings confirmed by the Henan Provincial Medical Device Testing Institute. This quality deviation led to the company's decision to recall the affected products.The recall, which commenced on March 20th, targeted a specific batch (01200205) of Type A (Earloop) masks. Of the 144,000 pieces produced, 132,000 had been sold in China. As a corrective action, the company promptly contacted all user units, requesting the uniform crushing and destruction of the recalled items. User units subsequently provided proof that all affected masks had already been utilized, and critically, no adverse reactions were reported.This action was undertaken within the regulatory framework overseen by the National Medical Products Administration (NMPA) and reported to the relevant Provincial Food and Drug Administration. The masks, registered under certificate code 豫械注准20162640415, are intended for clinical personnel during non-invasive procedures to provide a physical barrier against pathogens. The company's response aimed to address the quality issue and ensure public safety despite the complete usage of the affected products.