China NMPA Product Recall - Diffused braided artificial blood vessels

Intervascular (Shanghai) Medical Equipment Co., Ltd. announced on January 6, 2022, the voluntary Class III recall of Dipolluted Braided Artificial Blood Vessels manufactured by Intervascular SAS. This action was prompted by discrepancies found between the model and specification information presented on the inner and outer packaging labels of the affected medical devices.

The recall pertains to products registered under Certificate No. 国械注进20173460601. This regulatory action falls under the purview of the National Medical Products Administration (NMPA) and was reported via the Shanghai Municipal Drug Administration Website, underscoring adherence to China's medical device regulatory framework. A Class III recall typically signifies a situation where the use of or exposure to a violative product is not likely to cause adverse health consequences.

While specific inspection dates are not detailed in this recall announcement, the company has taken proactive steps to address the packaging inconsistencies. Affected product models, specifications, and batch numbers are provided in an accompanying "Medical Device Recall Event Report Form," which stakeholders can access for detailed information. This voluntary recall demonstrates the company's commitment to product integrity and compliance with regulatory standards, ensuring the accuracy of product information for patient safety.