China NMPA Product Recall - Disposable sterile peripheral central venous catheter kit

Zhengzhou Dior Medical Technology Co., Ltd. initiated a voluntary Level III recall of specific batches of its Disposable Sterile Peripheral Central Venous Catheter Kits. This action, reported to the National Medical Products Administration (NMPA) on November 12, 2018, was prompted by a critical non-compliance issue: the ethylene oxide residue detection method used for these medical devices did not meet required standards. The affected products include batches 8006202K (400 sets) and 8002602 (52 sets), registered under National Medical Device Registration Certificate 20163771537, which are designed for vascular access, blood sampling, and medication administration. The company promptly notified customers to cease using the identified products and proceeded with their recall from the market. All retrieved units were subsequently destroyed. In response to the identified deficiency, Zhengzhou Dior Medical Technology Co., Ltd. implemented several corrective actions. They re-constructed the standard curve for ethylene oxide detection, retested the product, and confirmed that the results now meet regulatory requirements. A comprehensive risk assessment was conducted, concluding that products already used would not pose harm to patients. Additionally, the company undertook retraining for its testing personnel to prevent recurrence of similar issues, demonstrating adherence to quality assurance principles under the NMPA's regulatory framework.