China NMPA Product Recall - Support catheter

The National Medical Products Administration (NMPA) issued a voluntary recall notice (Index No. JGXX-2019-10769) on November 18, 2019, regarding a medical device manufactured by Cook Incorporated. The recall, reported by Cook (China) Medical Trading Co., Ltd., pertains to specific batches of a support catheter, identified by Registration Certificate No. 国械注进20163771336. The primary reason for this corrective action is an identified error in the manufacturing process. While no specific inspection dates are provided, the recall itself represents a regulatory response to the discovery of this quality issue, ensuring product safety. The regulatory framework governing this action is the NMPA in China, which oversees medical device quality and compliance. The recall has been designated as Class II, indicating a potential for temporary or medically reversible adverse health consequences, or a remote probability of serious health consequences. As a required action, Cook Incorporated is undertaking a voluntary recall of all implicated support catheters. Detailed information concerning the specific models, specifications, and batch numbers involved is available in the accompanying "Medical Device Recall Event Report Form," facilitating proper identification and management of affected products by healthcare providers and consumers. This action highlights the manufacturer's dedication to maintaining product safety standards and adhering to NMPA regulations.