China NMPA Product Recall - Disposable sterile surgical gown

The National Medical Products Administration (NMPA) announced on November 9, 2017, a voluntary Level III recall initiated by Xinxiang Dafang Medical Device Manufacturing Co., Ltd. This recall pertains to a specific batch of their disposable sterile surgical gowns. The primary reason for the recall was the discovery that these products failed to meet required standards for both sleeve burst strength and lateral tensile strength in non-critical areas. Xinxiang Dafang Medical Device Manufacturing Co., Ltd. proactively reported these findings, leading to their decision to recall the affected medical devices. While specific inspection dates are not detailed in the provided information, the company's action was a response to internal quality control findings. The NMPA serves as the regulatory authority overseeing such medical product safety events in China, ensuring compliance with established standards for medical devices. A Level III recall typically indicates a situation where exposure to a violative product is not likely to cause adverse health consequences. The required action for the company was the immediate recall of the identified batch of surgical gowns to prevent further distribution and use of non-conforming products.