China NMPA Product Recall - Medical cold light source

Shandong Guanlong Medical Supplies Co., Ltd. initiated a voluntary Class III recall of its medical cold light sources, as reported on August 2, 2022, by the National Medical Products Administration (NMPA) and the Shandong Provincial Drug Administration. This recall was prompted by observations from random inspections, which revealed that the devices' red-green-blue light auxiliary flux ratio did not comply with specified requirements. The affected products, bearing Registration Certificate No.: Lu Xie Zhu Zhun 20162060424, are being withdrawn from circulation to address this non-conformance. A Class III recall signifies that the use of or exposure to the violative product is unlikely to cause adverse health consequences. Shandong Guanlong's voluntary action reflects its commitment to maintaining product quality and ensuring patient safety under the NMPA's regulatory oversight. Further specifics regarding the models, specifications, and batch numbers of the recalled devices are detailed in the accompanying "Medical Device Recall Event Report Form," ensuring that all non-compliant units are effectively removed from the market.