China NMPA Product Recall - chorionic villus sampling needle kit

William A. Cook Australia, Pty. Ltd., in conjunction with its Chinese entity, COOK (China) Medical Trading Co., Ltd., issued a voluntary Class III recall on July 2, 2018, as reported by the National Medical Products Administration (NMPA) on July 12, 2018. The recall pertains to specific batches of Villus Microscopy Needle Kits (Registration Certificate No.: 20153150273) manufactured before June 4, 2018. The primary issue identified was a labeling error on the product's English packaging. The label incorrectly stated that the 18-gauge guide needle tip was radiopaque and the 21-gauge sampling needle tip was non-radiopaque. According to the product's design specifications, the 21-gauge sampling needle should be radiopaque, and the 18-gauge guide needle non-radiopaque. Despite this discrepancy, the company assessed the risk as extremely low. The larger 18-gauge guide needle remains easily visible under ultrasound even without a radiopaque tip, and the labeling error does not impact the product's functionality or tip angiography process. Consequently, it is deemed unlikely to cause adverse patient events. Operating under the oversight of the NMPA, the recall was initiated globally. However, COOK (China) Medical Trading Co., Ltd. confirmed that no affected batches of these Villus Microscopy Needle Kits were imported or distributed within the Chinese market. Therefore, no specific actions or handling measures were required for products in China.