China NMPA Product Recall - Cleaning and sterilizing equipment

Maikewei (Shanghai) Medical Equipment Co., Ltd. has initiated a voluntary Class II recall of its cleaning and disinfecting devices, a measure reported by the National Medical Products Administration (NMPA) on December 28, 2020. The company proactively identified a significant safety issue concerning the inlet plastic hose connector in these medical devices. Investigations revealed that material aging or excessively tight hose clamps could lead to the deformation or breakage of this critical connector. Such a failure presents a direct risk of leakage and spraying during device operation, potentially compromising safety and effectiveness for healthcare professionals and patients. In a demonstration of its commitment to product quality and customer well-being, Maikewei is undertaking this recall to address the identified non-conformity. This action, managed under the NMPA's regulatory oversight, ensures that affected products are promptly removed from circulation. Detailed information regarding the specific models, specifications, and serial numbers of the recalled devices is provided in the associated Medical Device Recall Event Report Form, guiding customers on necessary steps to mitigate potential hazards.