China NMPA Product Recall - Non-invasive ventilator

Nanjing Shupusida Medical Equipment Co., Ltd. has initiated a voluntary Class III recall for its non-invasive ventilators (Certificate Code: Su Xie Zhu Zhun 20172540495). This action stems from a non-compliance identified during a 2019 national medical device spot check, where the external markings on the devices were found to be deficient and did not meet required standard specifications. The National Medical Products Administration (NMPA) publicly announced this recall on March 26, 2020, through the Jiangsu Provincial Drug Administration Website. A Class III recall, as designated by the NMPA, signifies that the product defect is unlikely to cause adverse health consequences, yet correction is necessary to ensure full regulatory adherence. The primary issue concerns essential product information displayed externally, which is crucial for proper identification, usage, and safety. Nanjing Shupusida Medical Equipment Co., Ltd. is undertaking the required actions by voluntarily recalling all affected models, specifications, and specific batches of the non-invasive ventilators. Comprehensive details regarding the scope of the recall are available in the "Medical Device Recall Event Report Form." This proactive measure by the company demonstrates a commitment to resolving identified deficiencies and maintaining compliance with national medical device standards to safeguard public health.