China NMPA Product Recall - Ureteral diversion stent

Cook Incorporated, a medical device manufacturer, has initiated a voluntary Class III recall of specific batches and models of its ureteral diversion stents. This action, reported by Cook (China) Medical Trading Co., Ltd., is in response to a significant packaging error. The primary issue identified is the absence of a left-side stent in the packaging of certain affected products. The recall is overseen by the National Medical Products Administration (NMPA), as indicated by the document's indexing and publication details. While specific inspection dates are not provided, the recall was publicly announced on March 26, 2021. The NMPA document, bearing index number JGXX-2021-10135, highlights the manufacturer's proactive measure to address the non-conforming products. Affected product models, specifications, and batch details are made available in an attached "Medical Device Recall Event Report Form." This voluntary recall ensures patient safety and product integrity by removing potentially incomplete devices from circulation. Cook Incorporated is taking corrective actions to mitigate the risk associated with these packaging discrepancies, underscoring their commitment to regulatory compliance and quality assurance under the NMPA's framework.