China NMPA Product Recall - Polysulfone membrane dialysis filter

B. Braun (Shanghai) Trading Co., Ltd. initiated a voluntary Class III recall of its polysulfone membrane dialysis filters, an action publicly announced on May 8, 2020. This decision stemmed from findings during the company's global post-market surveillance, which identified occasional leakage issues originating from one of the dialyzer caps. The affected products encompass specific models, specifications, and batch numbers, with comprehensive details provided in an accompanying Medical Device Recall Event Report Form. This regulatory measure falls under the oversight of the National Medical Products Administration (NMPA) of China, with the announcement disseminated via the Shanghai Municipal Drug Administration Website. The voluntary recall highlights the company's commitment to ensuring product quality and patient safety, addressing potential manufacturing or design vulnerabilities. A Class III recall indicates that the use of, or exposure to, the violative product is not likely to cause adverse health consequences. Stakeholders are advised to consult the attached report for precise identification of the recalled devices and to implement necessary return or disposal protocols, ensuring compliance with regulatory directives and mitigating any potential risks associated with the identified defect.