China NMPA Product Recall - Disposable sterile syringe with needle

Nanyang Jiukang Medical Device Co., Ltd. initiated a voluntary Level III recall for a specific batch of its disposable sterile syringes with needles, as reported to the Provincial Food and Drug Administration Department within the National Medical Products Administration (NMPA) regulatory framework. The recall, effective December 14, 2020, addresses a significant quality issue identified during national sampling inspections. The primary concern involves a non-compliance between the needle hub and sheath of the affected syringes. Inspections revealed that the fit required excessive force for separation, with the separation force exceeding established standards in some products. This defect could potentially impede medical personnel by increasing the effort needed to remove the needle sheath during drug administration or blood aspiration, impacting operational efficiency and user experience. The recall targets batch number 20200305 of the 5ml 0.7×30 TWLB model, comprising 48,000 units distributed across Hebei and Shandong provinces. Nanyang Jiukang Medical Device Co., Ltd. has instructed its distributors to immediately halt sales of the identified batch. Required actions include the recall of all unused products from the market for replacement by the company, followed by the systematic destruction of the retrieved non-compliant devices. This proactive measure underscores the company's commitment to product safety and regulatory compliance.