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

Longkou Kanghua Medical Device Co., Ltd., operating under the regulatory framework of the National Medical Products Administration (NMPA), initiated a voluntary Level III recall of its medical bed-type air cushion product. This recall, publicly announced on December 17, 2018, specifically affects products from Batch No. 20170601. The main issues identified were that the output air pressure of the medical bed-type air cushions exceeded the established product registration standard pressure value. Furthermore, the marking durability test results were unsatisfactory, indicating a deviation from required quality specifications. The company proactively reported these findings and implemented the recall for products registered under No. Lu Shi Yao Jian Xie [Zhun] Zi 2014 No. 2540639. A Level III recall typically indicates that the product is unlikely to cause adverse health consequences. This measure reflects the company's commitment to ensuring product safety and compliance with NMPA regulations, safeguarding patient well-being by addressing performance and quality control deficiencies.