China NMPA Product Recall - Double pigtail silicone ureteral stent

The National Medical Products Administration (NMPA) announced a voluntary Level III recall initiated by Cook (China) Medical Trading Co., Ltd., published on July 13, 2021. The recall concerns the company's 6Fr double-pigtail silicone ureteral stent, specifically model 133626, batch number 13512726. The core issue identified was that the fixation strength test results for this particular batch failed to meet the specified standards outlined in the product's technical requirements. This non-compliance prompted Cook (China) Medical Trading Co., Ltd. to proactively recall the affected medical device. The NMPA, operating under its regulatory framework, oversees such actions to uphold medical device safety and efficacy within the region. The required action for the company involved conducting a voluntary recall of the non-compliant product to address potential risks. The announcement provides specific product details to aid the recall process, indicating that further information is available in the 'Medical Device Recall Event Report Form'.