China NMPA Product Recall - Central venous catheters and accessories for blood purification centers

Bard Medical Technology (Shanghai) Co., Ltd. initiated a voluntary Class II recall of specific central venous catheters and blood purification accessories, as announced by the National Medical Products Administration (NMPA) on May 22, 2019. The recall, reported through the Shanghai Food and Drug Administration, stems from the discovery of a potential risk: the plastic barbed tip of the tunneling device in certain products may break. This issue affects devices with Registration Certificate No. 20153663072. The company is taking proactive measures to address this product integrity concern, safeguarding patient safety and ensuring compliance with regulatory standards. Detailed information on the models, specifications, and batches of the affected products is available in the 'Medical Device Recall Event Report Form' provided by the NMPA. The recall demonstrates the company's commitment to product quality and adherence to the regulatory framework governed by the NMPA in China.