China NMPA Product Recall - embolization spring coil

On June 12, 2019, the National Medical Products Administration (NMPA) of China publicized a voluntary Class III recall concerning Embolization Coils manufactured by William Cook Europe ApS. The recall was formally reported by Cook (China) Medical Trading Co., Ltd., the local entity. The core issue prompting this action was the identification of potential labeling errors on the affected products. While specific inspection dates are not provided in this announcement, the regulatory framework governing this action is the NMPA's medical device oversight. The recalled products, identified by Registration Certificate No.: ". The NMPA requires companies to address such discrepancies to maintain product integrity and patient safety. William Cook Europe ApS initiated this recall as a required action to rectify the labeling discrepancies and ensure compliance. This measure underscores the commitment to product integrity and accurate information dissemination in the medical device sector, operating under the NMPA's regulatory directives to safeguard public health. Further details regarding specific models, specifications, and batch numbers are documented in the accompanying Medical Device Recall Event Report Form.