China NMPA Product Recall - NGage Nitinol Ston Stone Retrieval Basket

Cook Incorporated has initiated a voluntary recall of its NGage Nitinol Stone Retrieval Baskets following the discovery of significant labeling errors. The National Medical Products Administration (NMPA) document, dated February 5, 2024, details this action by Cook (China) Medical Trading Co., Ltd. The primary issue identified involves incorrect production and expiration dates printed on the product labels. This mislabeling could potentially mislead users regarding the product's shelf-life and suitability for use, though the specific impact on patient safety is not explicitly stated as high-risk, given the Class III recall designation. The recall applies to products registered under National Medical Device Registration Certificate No. 20172026102. A Class III recall typically signifies a situation where use of or exposure to a violative product is not likely to cause adverse health consequences. Cook Incorporated has provided detailed information on the affected product models, specifications, and batch numbers in an attached Medical Device Recall Event Report Form, underscoring their commitment to rectify the labeling discrepancies and maintain product integrity within the regulated medical device market.