China NMPA Product Recall - Dilatators, disposable central venous catheter kits, angiography catheters, vascular sheaths, embolization coils, hydrophilic-coated guidewires, and emergency cricothyrotomy catheters.

Cook Incorporated, through its subsidiary Cook (China) Medical Trading Co., Ltd., initiated a voluntary Level III recall of several medical devices. The recall, publicly announced by the National Medical Products Administration (NMPA) on November 14, 2022, addresses a critical issue: certain models and batches of products were found to be missing their essential instructions for use. This deficiency is a significant compliance concern within the regulatory framework governing medical devices. Affected products include a wide range of critical medical equipment such as dilatators, single-use central venous catheter kits, angiography catheters, vascular sheaths, embolization coils, hydrophilic coated guidewires, and emergency cricothyrotomy catheters. The company's required action involves retrieving these specific products from the market to ensure patient safety and regulatory adherence. Further detailed information regarding the precise models, specifications, and batches involved in this recall is available in the accompanying "Medical Device Recall Event Report Form" provided by Cook (China) Medical Trading Co., Ltd.