China NMPA Product Recall - Polysulfone membrane dialyzer

B. Braun (Shanghai) Trading Co., Ltd. initiated a voluntary Class II recall of its polysulfone membrane dialyzers, as announced by the National Medical Products Administration (NMPA) on August 29, 2017. The recall was prompted by an identified issue stemming from a change in the drying process during the manufacturing of these medical devices. This manufacturing process alteration led to a slight but increased probability of membrane breakage within the dialyzers. The affected products, identified under Medical Device Registration Certificate No. 20153450056, are subject to this recall. While specific inspection dates are not detailed in the announcement, the regulatory oversight is provided by the NMPA, which hosted the official recall notification. The company's proactive measure to voluntarily recall the product underscores its commitment to patient safety and product quality, addressing a critical component used in dialysis treatments. The "Medical Device Recall Event Report Form" contains further detailed information regarding the specific models, specifications, and batch numbers involved in this corrective action. This regulatory action ensures that potentially compromised medical devices are removed from circulation to prevent adverse patient outcomes associated with membrane integrity issues.