China NMPA Product Recall - Guidance tube

On February 25, 2019, Condis (Shanghai) Medical Device Co., Ltd. initiated a voluntary Class II recall of its guiding tubes, under the oversight of the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration. The recall involves products with Registration Certificate Nos. 20153771031 and 20183032568. The primary issue prompting this action was the discovery of a small number of fragments from worn outer packaging that had entered and become visible inside the sterile plastic bags. This defect compromises the sterility and integrity of the medical devices. Condis (Shanghai) Medical Device Co., Ltd. proactively took steps to remove the affected products from the market to mitigate any potential risks associated with the packaging breach. Detailed information regarding the specific product models, specifications, and batches involved in the recall is available in the accompanying Medical Device Recall Event Report Form.