China NMPA Product Recall - Single-use sterile intravascular catheters: balloon dilation catheters

On January 4, 2021, Shenzhen Yixinda Medical New Technology Co., Ltd. initiated a voluntary Class III recall of its single-use sterile intravascular catheters, specifically balloon dilatation catheters (Registration Certificate No. 20173770911). The company identified a critical error in the printing specifications on the production labels for these medical devices, prompting the immediate recall. This proactive measure was undertaken under the regulatory framework of the National Medical Products Administration (NMPA) in China, with the announcement made via the Guangdong Provincial Drug Administration. Although specific inspection dates were not detailed, the recall commenced on the discovery date of this significant labeling discrepancy. The primary issue was the inaccurate production label, which necessitates immediate corrective action. The required action involves the retrieval of all affected products from the market, with comprehensive details regarding specific specifications and batches outlined in the 'Medical Device Recall Event Report Form'. This recall highlights the imperative for precise product labeling to ensure patient safety and maintain stringent regulatory compliance within the global medical device industry.