China NMPA Product Recall - Absorbable surgical sutures

B. Braun Medical (Shanghai) International Trading Co., Ltd. initiated a Class II voluntary recall of Absorbable Surgical Sutures with Needles (Model C1048557, Batch Number 114261), manufactured by B.Braun Surgical, S.A. This recall, reported to the National Medical Products Administration (NMPA) on December 9, 2016, and publicly announced on December 29, 2016, addresses a critical product quality issue. The primary concern is that the inner aluminum foil packaging of a limited number of products in the affected batch was not airtight. This defect poses a risk of accelerated degradation of the surgical sutures, meaning the product does not meet its specified quality and performance standards. These sutures are designed for various surgical applications, including gastrointestinal, gynecological, urological, subcutaneous, ophthalmic, and microsurgery. The recall impacted 60 boxes imported into China, with a broader scope involving countries like Japan, the Philippines, and Germany. In response, B. Braun Medical (Shanghai) implemented several corrective actions. These include immediately locking all affected products in their ordering system and freezing existing inventory in China. The company is actively tracking affected customers using sales data, issuing formal recall notices, and requiring customers to return all unused products for confirmation.