China NMPA Product Recall - Disposable concentric circular needle electrode

Natus Manufacturing Limited initiated a Level III voluntary recall in China for its Disposable Concentric Circular Needle Electrodes (Registration No.: 20172210870). This action was reported by Natus Medical Instruments (Beijing) Co., Ltd. on June 14, 2017, and published by the National Medical Products Administration (NMPA) on July 19, 2017. The core issue was that the affected product batches, including 05A/17/T and 05B/17/T, totaling 319 units, were distributed and sold in China without product instructions and labels approved by the China Food and Drug Administration (CFDA). This constituted a direct violation of CFDA's "Regulations on the Administration and Management of Medical Device Instructions for Use (Order No. 6)". The instructions and labels compliant with CFDA requirements had not been released when these products entered the market, indicating a failure to meet China's import standards. As a corrective measure, Natus is proactively recalling the devices. Unaffected products are slated for return to the manufacturer's facility in Ireland, where further appropriate actions will be determined based on the returned items to rectify this regulatory discrepancy.