China NMPA Product Recall - Polysulfone membrane dialyzer

B. Braun (Shanghai) Trading Co., Ltd. initiated a voluntary Class III recall of its polysulfone membrane dialyzers, as officially reported by the National Medical Products Administration (NMPA) on May 8, 2020. This significant action stems from issues identified through diligent post-marketing monitoring, which revealed instances of occasional leakage from a dialyzer cap. The affected products are specifically polysulfone membrane dialyzers, identified under Registration Certificate No.: 国械注进 20163450092. The regulatory framework governing this recall involves the NMPA, with the Shanghai Municipal Drug Administration serving as the issuing authority for the recall notification. As a required action, B. Braun (Shanghai) Trading Co., Ltd. is systematically withdrawing all impacted batches from the market to mitigate potential risks and uphold patient safety standards. The company has provided comprehensive details regarding the specific models, specifications, and batch numbers involved in the "Medical Device Recall Event Report Form," demonstrating a commitment to transparency and adherence to regulatory compliance in addressing this product concern.