China NMPA Product Recall - Disposable sterile surgical gowns

Changdong Medical Device Group Co., Ltd. initiated a voluntary Class III recall of 300 units of its disposable sterile surgical gowns (model L, large size) in China, specifically Henan Province, Hebi City. This action, reported to the National Medical Products Administration (NMPA) on November 6, 2019, and published on December 16, 2019, was prompted by an inspection from relevant departments. The inspection identified that the surgical gowns partially failed to meet established product technical requirements. These gowns are intended for surgical personnel to reduce the spread of infection to patients' surgical wounds. As part of the required actions, Changdong Medical Device Group Co., Ltd. committed to recalling all affected products within seven days for immediate processing. The company also outlined comprehensive corrective measures to prevent recurrence, including a thorough step-by-step inspection and testing of the manufacturing process and raw materials. Furthermore, the company will focus on selecting raw materials and processing methods that fully comply with product technical requirements, bearing all associated recall costs. This action highlights the company's commitment to product safety and regulatory compliance under the NMPA framework.