China NMPA Product Recall - Cardiopulmonary assist membrane oxygenator

Maikewei (Shanghai) Medical Equipment Co., Ltd. initiated a voluntary Class II recall of its cardiopulmonary assist membrane oxygenators on November 11, 2020. This action was reported by the Shanghai Municipal Drug Administration and falls under the oversight of the National Medical Products Administration (NMPA). The company discovered a potential risk of damage to the sterile packaging of the product during routine verification testing and in response to customer complaints. This issue raised concerns regarding the product's sterility and overall safety. The recall, impacting products with Registration Certificate No.: 国械注进20183451835, mandates the retrieval of affected units to address and mitigate potential health risks. A Class II recall indicates that the product may cause temporary or medically reversible adverse health consequences, with the probability of serious adverse health consequences being remote. The company has committed to providing detailed information on the specific models, specifications, and batches involved through a "Medical Device Recall Event Report Form," emphasizing its responsibility to customers and dedication to product safety.