China NMPA Product Recall - Importer

Cook Incorporated, through its Chinese subsidiary Cook (China) Medical Trading Co., Ltd., initiated a voluntary recall of its injection devices due to incorrect packaging labeling. This recall, reported by China's National Medical Products Administration (NMPA) on February 25, 2016, pertained to devices registered under CFDA (Imported) No. 20143770429. The primary issue identified was packaging that mistakenly indicated a 6.0Fr injector, whereas the actual product contained a 5.0Fr injector. Cook Incorporated received three complaints regarding this mislabeling, leading to the voluntary recall in the United States to mitigate potential patient risks. While no specific inspection dates were provided, the recall report was dated January 27, 2016. Operating under the regulatory framework of the NMPA, it was confirmed that no affected products were imported into or sold within the Chinese market. Consequently, no direct corrective actions were required from Cook (China) Medical Trading Co., Ltd. However, the NMPA advised provincial, autonomous region, and municipal food and drug administrations to strengthen their general oversight and management of similar medical devices to uphold product safety and compliance standards.