China NMPA Product Recall - Disposable sterile medical masks

Henan Kelong Medical Device Co., Ltd. initiated a voluntary Level III recall for a batch of its disposable sterile medical masks due to a significant non-compliance issue. The recall, reported on November 30, 2020, and published by the National Medical Products Administration (NMPA) on December 4, 2020, stemmed from product sampling conducted by the Henan Provincial Drug Administration. Testing by the Henan Provincial Medical Device Testing Institute revealed that the ear loops of the masks failed the required tensile strength test. Under the regulatory oversight of the NMPA, Henan Kelong Medical Device Co., Ltd. was instructed to implement a Level III recall. This action required contacting all user units to retrieve and ensure the uniform crushing and destruction of the non-compliant masks. The affected products included 5100 units of Type A (Earloop) masks from batch 01200331, with 5000 units distributed within China. The company confirmed that all recalled masks had already been used by clinical personnel for their intended non-invasive procedures. Crucially, user units provided proof of use, and no adverse reactions were reported in connection with the use of the masks.