China NMPA Product Recall - Hollow fiber dialysis machine

Nipro Medical Devices (Hefei) Co., Ltd. initiated a voluntary Class III recall of its hollow fiber dialyzers, as reported by the National Medical Products Administration (NMPA) on February 9, 2021. The recall stems from the identification of an unqualified vitamin B12 clearance rate, meaning the devices failed to meet the required performance standards for effectively removing vitamin B12. This issue was first published on the Anhui Provincial Drug Administration website. The company proactively reported this deficiency, leading to the voluntary recall action. While specific inspection dates are not detailed, the recall notification itself is a key regulatory event. The regulatory framework for this recall falls under the NMPA, which oversees medical device safety and quality in China. The required action by Nipro Medical Devices (Hefei) Co., Ltd. was to execute a Class III recall, signifying that while a product defect is present, it is not expected to cause severe adverse health consequences. Further details regarding the specific models, specifications, and batches involved are available in the accompanying "Medical Device Recall Event Report Form," which supports the company's adherence to NMPA recall protocols. This action underscores the ongoing commitment to product quality and patient safety within the medical device industry.