China NMPA Product Recall - Disposable concentric circular needle electrode

Natus Manufacturing Limited initiated a voluntary, Level III recall of its Disposable Concentric Circular Needle Electrodes in China, as reported by Natus Medical Instruments (Beijing) Co., Ltd. on June 14, 2017, and published by the National Medical Products Administration (NMPA) on June 21, 2017. The primary reason for the recall was the failure of these medical devices to comply with Chinese regulatory requirements concerning product labeling and instructions. Specifically, the affected products, totaling 319 units across several batches (e.g., 05A/17/T, 05B/17/T), did not include instructions for use and labels approved by the China Food and Drug Administration (CFDA). This non-compliance was attributed to the CFDA-compliant documentation not being released at the time of the product's distribution. The recall was enacted to address this violation of the CFDA's "Regulations on the Administration and Management of Medical Device Instructions for Use" (Order No. 6). As a corrective action, all affected products are to be returned to Natus Manufacturing Limited's factory in Ireland for further assessment and appropriate measures. This proactive recall aims to ensure full adherence to China's medical device import and labeling standards.