China NMPA Product Recall - Disposable sterile surgical gown

On November 1, 2017, the National Medical Products Administration (NMPA) publicized a voluntary Level III recall initiated by Xinxiang Phoenix Medical Device Co., Ltd. concerning its disposable sterile surgical gowns. This action was prompted by the company's internal findings that specific batches of these gowns failed to meet established quality standards. The primary issue identified was a deficiency in the gowns' physical properties, specifically inadequate sleeve burst strength and compromised lateral tensile strength in non-critical areas. These deviations from standard requirements indicate potential quality concerns for the affected medical devices. While no specific inspection dates were mentioned, the recall report was published by the NMPA on the aforementioned date. Operating under the NMPA's regulatory framework, Xinxiang Phoenix Medical Device Co., Ltd. proactively undertook this voluntary recall. This measure is essential to mitigate potential risks associated with the non-conforming products and uphold patient safety. The affected models and specifications are detailed in the accompanying Medical Device Recall Event Report Form, guiding stakeholders on the necessary actions to remove these products from circulation.