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, following a report by its agent, Natus Medical Instruments (Beijing) Co., Ltd., on June 14, 2017. The recall, published by the National Medical Products Administration (NMPA) on July 18, 2017, affects 319 units across several batches (e.g., 05A/17/T, 05B/17/T) sold in China. The primary reason for the recall is non-compliance with the China Food and Drug Administration (CFDA) "Regulations on the Administration and Management of Medical Device Instructions for Use (Order No. 6)." Specifically, the affected products distributed in China lacked CFDA-approved product instructions and labels at the time of their release. This omission rendered the products non-compliant with CFDA import requirements, necessitating the proactive recall. As part of the corrective actions, all affected products are to be returned to the manufacturer's factory in Ireland for appropriate handling. Natus Medical Instruments (Beijing) Co., Ltd. is responsible for reporting on the resolution of this issue. This recall underscores the importance of stringent adherence to local regulatory frameworks for medical device distribution.