China NMPA Product Recall - Disposable medical masks and disposable medical protective clothing

Henan Sanyao Medical Device Co., Ltd. initiated a voluntary Class III recall, reported on September 19, 2020, and published by the National Medical Products Administration (NMPA) on September 30, 2020. This action followed market sampling results indicating product deficiencies. The recall affects two medical devices: disposable medical masks and disposable medical protective clothing. Specifically, 14,480 units of disposable medical masks (batch 20040210) were recalled because their ear straps failed tear strength tests, not meeting required breaking strength specifications. Additionally, 60 pieces of disposable medical protective clothing (batch 20052701) were recalled due to substandard transverse breaking strength. In response, Henan Sanyao is implementing several corrective actions. For the masks, the company is changing ear loop materials and strengthening finished product inspection. For the protective clothing, raw materials are being upgraded to a stronger variant, and both raw material and finished product inspections are being enhanced. Customers have been notified to retrieve any unused recalled products, which will be destroyed. The company aims to complete these recalls by the end of September 2020 and has committed to implementing internal corrective and preventive measures to prevent future recurrences.