China NMPA Product Recall - Wire Guides

On September 7, 2022, the National Medical Products Administration (NMPA) announced a voluntary Class II recall initiated by Cook Incorporated. The recall, reported by Cook (China) Medical Trading Co., Ltd., specifically targets certain models and batches of Cook Incorporated's "Wire Guides" (Product No.: 20153030949). The central issue leading to this action is the discovery of damaged sterilization packaging, which potentially compromises the sterility and safety of these medical devices. This proactive measure by Cook Incorporated demonstrates adherence to the NMPA's regulatory framework governing medical device safety and quality in China. While the document does not detail specific inspection dates, it outlines the company's required action to voluntarily recall the affected products. A Class II recall signifies that the product's use could lead to temporary or medically reversible adverse health consequences, or where the likelihood of serious adverse health consequences is remote. Cook Incorporated is mandated to manage the comprehensive recall process, which includes informing affected customers and ensuring the appropriate handling and disposition of the non-conforming products, as further detailed in the attached "Medical Device Recall Event Report Form".