China NMPA Product Recall - Vacuum blood collection tubes

The National Medical Products Administration (NMPA) issued a recall notice on June 16, 2017, regarding vacuum blood collection tubes manufactured by BD Medical Devices (Shanghai) Co., Ltd. The company initiated a voluntary Class III recall of these products due to the identification of visible foreign matter within them, which was found to affect the normal use and functionality of the devices. This action underscores the NMPA's role in overseeing medical device quality and ensuring patient safety within China's regulatory framework. The recall, referenced under NMPA Index No. JGXX-2017-10472, involved products with Registration No. 201524104. A Class III recall indicates that the use of, or exposure to, the affected product is unlikely to cause severe adverse health consequences. BD Medical Devices (Shanghai) Co., Ltd. is responsible for systematically removing the compromised vacuum blood collection tubes from the market. Further comprehensive details concerning the specific models, specifications, and batch numbers of the impacted devices are provided in an associated "Medical Device Recall Event Report Form," ensuring full transparency and facilitating effective recall procedures.