China NMPA Product Recall - Medical cotton balls and disposable suction kits

The National Medical Products Administration (NMPA) announced on October 11, 2019, that Xinxiang Huaxi Medical Supplies Co., Ltd. initiated a voluntary Level III recall for specific medical products following identified quality control issues. Medical device testing revealed that two batches of medical cotton balls (batches 18102609 and 18120809) failed to meet surface activity requirements. Additionally, one batch of disposable suction kits (batch 18090852) was found to have suction tubes with residual vacuum levels below the required standards. The company's internal recall reports for these issues were filed in August 2019 and September 2017. In adherence to NMPA regulations, Xinxiang Huaxi Medical Supplies Co., Ltd. is undertaking several corrective actions. These include: notifying all purchasers to immediately cease the sale and use of the affected products, retrieving all non-compliant units from the market, thoroughly investigating the root causes of these deficiencies, and implementing robust corrective and preventive measures. For one batch of the recalled medical cotton balls, destruction of the products was also a specified action.