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

The National Medical Products Administration (NMPA) reported on December 20, 2018, a voluntary Level Three recall by Longkou Kanghua Medical Device Co., Ltd. for its medical bed-type air cushion product, specifically batch number 20170601. The recall was initiated because the product's output air pressure surpassed the established product registration standard pressure value. Additionally, the device failed to meet the requirements of a mark durability test. These issues indicate non-compliance with the regulatory framework set by the NMPA, as indicated by its registration number Lu Food and Drug Administration [Approval] No. 20142540639. In response to these identified quality deficiencies, Longkou Kanghua Medical Device Co., Ltd. implemented a voluntary recall. A Level Three classification for this recall signifies that the identified product issues are unlikely to cause significant adverse health consequences. This action demonstrates the company's commitment to addressing product quality and upholding regulatory standards.