China NMPA Product Recall - Integrated membrane oxygenator, arterial filter, and venous blood storage device

On December 23, 2020, Makro (Shanghai) Medical Equipment Co., Ltd. announced a voluntary Class II recall affecting multiple critical medical devices. This significant action followed internal validation testing conducted by the company, which uncovered a potential risk of breakage in the sterile packaging of its venous blood storage devices (VHK) and pediatric oxygenators (VKMO). Recognizing its responsibility to ensure product safety and integrity for customers, Makro (Shanghai) proactively initiated the recall. The affected products include integrated membrane oxygenators, arterial filters, and venous blood storage devices, all registered under certificate number 国械注进20163454677. The recall process operates under the regulatory framework of the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration. The main issue, compromised sterile packaging, poses a potential risk to patient safety as it could affect the sterility of the devices during use. To facilitate the recall, the company directed stakeholders to a "Medical Device Recall Event Report Form" for comprehensive details on the specific models, specifications, and batch numbers involved. This measure underscores the company's commitment to swiftly address and mitigate potential health risks associated with its products, ensuring compliance with established medical device safety standards.