China NMPA Product Recall - Disposable infusion set (with needle)

Hunan Oasis Huikang Development Co., Ltd. initiated a voluntary Class III recall of 5,000 units of its disposable infusion sets (with needles), specifically Batch 20200421 (Registration No.: "," Xiang Xie Zhu Zhun 20163661016). This action was prompted by random inspections conducted by the Anhui Provincial Drug Administration in late December 2020. The inspections revealed that the "drip chamber and hard dropper" component of the product failed to meet the registered product technical requirements, specifically section 2.1.8.1 of the National Medical Device Registration Standard 20163661016. The company's subsequent quality analysis determined the non-compliance stemmed from a temporary production process change, where improper adhesive application by employees caused the dropper tip to shrink, resulting in a slight reduction in drip weight. Under the regulatory oversight of the National Medical Products Administration (NMPA) and its provincial counterparts, Hunan Oasis Huikang Development Co., Ltd. promptly corrected the production process and implemented comprehensive corrective and preventative measures to avoid recurrence. The recall ensures the retrieval of all affected units sold, upholding product quality and patient safety standards.