China NMPA Product Recall - Disposable sterile surgical gown

Xinxiang Dafang Medical Device Manufacturing Co., Ltd. announced a voluntary Class III recall of its disposable sterile surgical gowns, as reported by the National Medical Products Administration (NMPA) on November 9, 2017. The recall was initiated after the company discovered that specific batches of the surgical gowns failed to meet required standards for sleeve burst strength and lateral tensile strength in non-critical areas. This deficiency indicates a potential quality issue with the product's material integrity. The company, operating under the oversight of the NMPA, took the proactive step of recalling the affected products to ensure patient safety and compliance with medical device regulations. The required action involves the complete removal of the non-conforming disposable sterile surgical gowns from the market. Further details regarding the specific models and specifications of the recalled products are contained in the company's Medical Device Recall Event Report Form.