China NMPA Product Recall - Disposable oxygen masks

Chongqing Century Changhe Industrial Co., Ltd. initiated a voluntary Class III recall of its disposable oxygen masks (Registration No.: "渝械注准2015256158") due to identified manufacturing deficiencies. The recall report was submitted on December 3, 2019, with a public announcement by the National Medical Products Administration (NMPA) on December 24, 2019. The primary issue stems from mold wear during the production process, affecting the physical performance and connection firmness of certain products within batch 20190218, produced on February 18, 2019. Specifically, the connector and mask components of the Adult Large (L) models were found unable to withstand a static tensile force of 20 Newtons for 15 seconds without detaching, indicating a failure to meet essential product requirements. A total of 14011 units were produced, with 13920 units sold across regions including Chongqing, Sichuan, and Jiangsu, China. Under the NMPA's regulatory framework, the company is required to issue recall notices to all distributors and medical institutions. These entities must immediately cease sales of the affected disposable oxygen masks and return them to Chongqing Century Changhe Industrial Co., Ltd. within 15 days of notification. The company has committed to reworking the recalled products to rectify the identified quality issues, ensuring compliance with safety and performance standards.