China NMPA Product Recall - Absorbable surgical sutures (trade name: Novosyn)

B. Braun Medical (Shanghai) International Trading Co., Ltd. initiated a voluntary Class III recall of its absorbable surgical sutures, marketed under the trade name Novosyn, as announced by the National Medical Products Administration (NMPA) on April 29, 2019. This action, referenced under Shanghai Food and Drug Administration Recall No. 2019-097, was prompted by a significant quality control issue where the suture diameter failed product sampling inspection. The affected medical devices, registered under Certificate No. CFDA (Imported) 2013 No. 3652572, are detailed in a 'Medical Device Recall Event Report Form' that specifies the model, specifications, and batch numbers. This proactive recall demonstrates the company's adherence to regulatory standards enforced by the NMPA and the Shanghai Food and Drug Administration, ensuring product safety and quality within the medical device market. The recall requires relevant parties to consult the attached report for comprehensive details on the impacted products.