China NMPA Product Recall - Disposable oxygen masks

Chongqing Century Changhe Industrial Co., Ltd. initiated a Class III voluntary recall of its disposable oxygen masks (Registration No.: 渝械注准2015256158). The recall was publicly announced on October 22, 2020, following an internal report dated December 3, 2019. The primary issues stemmed from production department mold wear and, more critically, product defects concerning physical performance and connection firmness. Specifically, a batch identified as 20190218, produced on February 18, 2019, failed to meet required standards; the connector and mask could not withstand a static tensile force of 20N without detaching within 15 seconds, impacting product reliability for oxygen inhalation.Under the oversight of the National Medical Products Administration (NMPA), Chongqing Century Changhe Industrial Co., Ltd. is taking decisive actions. The company committed to dispatching recall notices to all affected medical institutions and operating units across Chongqing, Sichuan, and Jiangsu, China, where 13,920 units were sold. These entities are instructed to immediately cease selling the affected Adult Large (L) model masks. Furthermore, all units must be returned within 15 days from the notice date for rework by the manufacturer, ensuring patient safety and product quality compliance.