China NMPA Product Recall - Angiography catheter

Cook (China) Medical Trading Co., Ltd., on behalf of its parent company, Cook Incorporated of the United States, initiated a voluntary Class I recall of angiography catheters in China, as reported by the National Medical Products Administration (NMPA) on November 17, 2015. This action was prompted by customer complaints received by Cook Inc. concerning catheter tip cracking and/or separation in the affected devices. A global recall of certain product batches began in July 2015, with an expanded scope for the recall announced on October 7, 2015. This Class I designation indicates a serious potential health risk associated with the product defect.

Operating under the NMPA’s regulatory framework and adhering to relevant national regulations, Cook (China) Medical Trading Co., Ltd. managed the recall process within China. Key actions included notifying distributors in writing within one day, instructing them to return all unused affected products. Distributors were also tasked with informing product-using institutions to return any unused devices, with Cook (China) committing to providing appropriate compensation for these returns. All recalled devices are scheduled for uniform destruction. The company clarified that patients who had already utilized these single-use products do not require specialized follow-up treatment beyond standard clinical care, emphasizing its dedication to patient safety.