China NMPA Product Recall - vena cava filter

Cook (China) Medical Trading Co., Ltd. initiated a voluntary Class III recall of its vena cava filters, as announced by the National Medical Products Administration (NMPA) on March 5, 2019. The primary reason for this recall was an update to the product instructions for the affected medical devices. This action falls under the regulatory oversight of the NMPA and the Shanghai Food and Drug Administration, which issued relevant medical device registration certificates (Nos.: 20153772630, 20183132482). A Class III recall typically signifies a situation where use of or exposure to a violative product is not likely to cause adverse health consequences. The company provided detailed information on the specific models, specifications, and batch numbers of the recalled products in an accompanying Medical Device Recall Event Report Form. This recall demonstrates Cook (China) Medical Trading Co., Ltd.'s adherence to regulatory requirements and commitment to product safety following changes in product documentation.