China NMPA Product Recall - Disposable infusion pump

Nanjing Yangzi Medical Products Co., Ltd. initiated a Class III voluntary recall of its Disposable Infusion Pumps on January 16, 2019. This action followed a 2018 national medical device spot check by the National Medical Products Administration (NMPA), which revealed that certain batches of the infusion pumps failed to meet "ultraviolet absorbance" standards. Specifically, the ultraviolet absorbance value exceeded the permissible limit at a wavelength of 220um. The company's investigation determined the primary cause to be a manufacturing process issue at its supplier. During the boiling of liquid reservoirs, some components were not fully submerged due to worn boiling frame lids, leading to incomplete processing of silicon capsules. This resulted in unsaturated small molecule compounds remaining, which caused the elevated ultraviolet absorbance readings. In response, Nanjing Yangzi Medical Products Co., Ltd. implemented several corrective actions. The affected batch of 400 units (Batch Number: 18032300), which had not been sold, is slated for destruction in collaboration with the regulatory authorities. The company conducted additional spot checks on other production batches, confirming their compliance. Furthermore, the supplier was formally notified to rectify their boiling process, emphasizing strict adherence to operating instructions and implementing dual-person control for critical processing steps. Internally, Nanjing Yangzi Medical Products Co., Ltd. enhanced its quality control by incorporating ultraviolet absorbance testing into the raw material inspection process for all infusion pump accessories. These measures aim to prevent recurrence and ensure product quality.