China NMPA Product Recall - Hollow fiber dialyzer/hemodialysis filter

Nipro Medical Devices (Hefei) Co., Ltd. initiated a voluntary Class II recall of its hollow fiber dialyzers and hemodialysis filters, as announced by the National Medical Products Administration (NMPA) on June 28, 2022. The recall stems from an identified abnormal risk of membrane rupture and leakage in these critical medical devices. The affected products include those under Registration Certificate No. 20173103117 and National Medical Device Registration Certificate No. 20203100611. While the document does not specify inspection dates, the company proactively reported the issue and commenced the recall to ensure patient safety. Details regarding the specific models, specifications, and batch numbers involved in this action are provided in an attached Medical Device Recall Event Report Form. This voluntary recall demonstrates the company's commitment to regulatory compliance and patient welfare under the NMPA's oversight.