China NMPA Product Recall - drainage tube

On December 23, 2019, Cook (China) Medical Trading Co., Ltd. initiated a voluntary Class II recall of its manufactured drainage catheters. This action was prompted by a significant product quality issue: non-standard manufacturing practices led to a potential defect where leakage could occur at the Mac-Loc locking connection of the catheter. This type of malfunction poses a risk to patient safety and product efficacy. The recall was reported through official channels, specifically the National Medical Products Administration (NMPA), with the Shanghai Municipal Drug Administration website serving as the source of the announcement (Index No. JGXX-2019-10860). The regulatory framework governing this recall is established by the NMPA, which oversees medical device safety and quality in China. The specific products involved are identified by Registration Certificate No.: 国械注进20192142121, with further details on models, specifications, and affected batches available in an accompanying "Medical Device Recall Event Report Form." Cook (China) Medical Trading Co., Ltd.'s proactive measure to recall these devices demonstrates adherence to regulatory responsibilities to mitigate potential risks associated with their products. A Class II recall indicates that the product may cause temporary or medically reversible adverse health consequences, or that the probability of serious adverse health consequences is remote. This recall underscores the critical importance of stringent manufacturing standards in the medical device industry to ensure product reliability and patient well-being.