China NMPA Product Recall - Medical surgical masks

On January 17, 2019, the National Medical Products Administration (NMPA) announced that Zhende Medical Supplies Co., Ltd. initiated a voluntary Class 3 recall of its medical surgical masks. The recall, formally reported on December 20, 2018, impacts masks with Registration Certificate No.: Zheshiyaojianxie (Zhun) 2014 No. 2640905, specifically Type 1, 17×18cm-3p, from production batch number 20180118. A total of 30,000 units were affected and sold within China. The primary issue necessitating this recall was the failure of the mask's strap connection points to meet required technical specifications for tensile strength. This non-conformance was identified during a national medical device supervision and inspection conducted under the NMPA's regulatory framework. The masks are designed for basic protection of medical personnel and for blocking blood, body fluids, and splashes during invasive procedures. In response to this finding, Zhende Medical Supplies Co., Ltd. implemented two critical corrective actions. Firstly, all distributors were instructed to immediately cease sales of the identified problematic batch across all sales channels. Secondly, distributors were mandated to return all affected products of this batch to the company, ensuring the removal of substandard devices from the market.