China NMPA Product Recall - Ureteral stent tube

Cook Incorporated, through its subsidiary Cook (China) Medical Trading Co., Ltd., initiated a voluntary Class II recall of certain ureteral stents, as reported by the National Medical Products Administration (NMPA) on September 2, 2020. The recall stems from an issue involving the misplacement of different models and batches of these critical medical devices.

The NMPA document, bearing Index No. JGXX-2020-10430, highlights that the manufacturer, Cook Incorporated, identified a problem where incorrect ureteral stent models or batches were placed into packaging, leading to potential discrepancies between the product label and its contents. This type of mispackaging can pose significant risks in clinical settings if healthcare providers rely on external labeling for product identification.

Under the NMPA's regulatory framework, a Class II recall signifies a situation where the use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. Cook Incorporated’s required action is the voluntary recall of the affected ureteral stents, specifically those under Registration Certificate No.: 20153142099. Detailed information regarding the specific models, specifications, and batch numbers impacted by this recall is available in the "Medical Device Recall Event Report Form" attachment, guiding healthcare facilities and distributors on identifying and returning affected products.