China NMPA Product Recall - Percutaneous intrahepatic portal vein puncture kit

The National Medical Products Administration (NMPA) announced on July 26, 2023, a Class III voluntary recall initiated by Creganna Medical for its Percutaneous Hepatic Portal Vein Puncture Kits. This action, reported by Gore Industrial Products Trading (Shanghai) Co., Ltd., stems from the identification of an incorrect expiration date on the affected medical devices. The product holds National Medical Device Registration Certificate No. 20233030268. A Class III recall signifies that exposure to the product is not likely to cause adverse health consequences, yet the company is taking corrective action to address the labeling discrepancy. This measure falls under the regulatory framework of the NMPA, which oversees medical device safety and compliance in China. Required actions include the withdrawal of affected kits from the market, with specific details concerning product models, specifications, and batch numbers available in the 'Medical Device Recall Event Report Form' attached to the official notice. This incident underscores the critical importance of accurate product information and adherence to stringent labeling standards within the medical device industry to ensure patient safety and product integrity.