China NMPA Product Recall - Disposable sterile urinary catheter

Dentsply Sirona Dental Products (Shanghai) Co., Ltd., on June 29, 2020, initiated a voluntary Class II recall of its disposable sterile urinary catheters. The manufacturer, Wellspect HealthCare (a division of Dentsply IH AB), discovered during routine sampling that the product's tip was damaged and lodged within its sealed packaging. This critical defect compromises the sterility and functionality of the medical device, posing potential risks to patient safety and treatment efficacy. The recall action is overseen by the National Medical Products Administration (NMPA) and was reported via the Shanghai Municipal Drug Administration. A Class II recall is typically enacted when a product may cause temporary or reversible adverse health consequences, or when the probability of serious adverse health consequences is remote, emphasizing the need for corrective measures. While specific inspection dates are not detailed in the document, the issue was identified through established quality control protocols. Dentsply Sirona Dental Products (Shanghai) Co., Ltd. is responsible for implementing the recall, ensuring the removal of all affected models, specifications, and batches from the market. Comprehensive details regarding the involved products are provided in an attached Medical Device Recall Event Report Form. This action reflects the company's commitment to upholding product quality and adhering to stringent regulatory standards established by the NMPA.