China NMPA Product Recall - Medical bed-type air mattress products

Longkou Kanghua Medical Device Co., Ltd. has initiated a voluntary Level Three recall for its Medical Bed-Type Air Cushion Product, specifically Batch No. 20170601. This action, reported on December 17, 2018, falls under the regulatory oversight of the National Medical Products Administration (NMPA) in China. The recall was prompted by significant non-conformities identified with the product. Investigations revealed two primary issues: the output air pressure of the medical air cushion exceeded its established product registration standard pressure value, and the product failed to pass the required mark durability test. These findings indicate potential deviations from approved specifications and quality standards, which could impact product performance and user safety. As a result, Longkou Kanghua Medical Device Co., Ltd. undertook a voluntary recall, classified as Level Three, to address these critical issues. This proactive measure ensures compliance with regulatory requirements set forth by the NMPA, emphasizing the need for medical device manufacturers to maintain stringent quality control and adherence to registered product standards to safeguard public health. Further detailed information regarding specific product models, specifications, and batch numbers is available in the accompanying Medical Device Recall Event Report Form.