China NMPA Product Recall - Disposable sterile ureteral stent kit

The National Medical Products Administration (NMPA) announced on July 19, 2021, that Xiamen Xinkangshun Medical Technology Co., Ltd. is initiating a voluntary Class III recall of its Disposable Sterile Ureteral Stent Kits. This action follows a medical device supervision and spot check, which identified significant quality control issues with the product.

Specifically, the recall targets batch number 32010014 due to non-compliance concerning the fixation strength and elongation rate of the stent kits. These critical parameters are essential for the safe and effective performance of ureteral stents, used in medical procedures to maintain urine flow. Failures in these areas could compromise patient safety and the therapeutic efficacy of the device.

The recall is being managed under the regulatory oversight of the NMPA, with the Fujian Provincial Drug Administration Website publishing the initial notification. While specific inspection dates were not detailed, the "spot check" triggered the company's decision to voluntarily remove the affected products from the market. Xiamen Xinkangshun Medical Technology Co., Ltd. is responsible for implementing this recall, ensuring all non-compliant units are properly accounted for and removed, in line with NMPA's medical device recall regulations. Further detailed information regarding specific models and specifications is available in the company's Medical Device Recall Event Report Form.