China NMPA Product Recall - Medical-grade anti-adhesion modified chitosan (membrane)

Beijing Bailikang Biochemical Co., Ltd. initiated a Class III voluntary recall of its Medical-Grade Anti-Adhesion Modified Chitosan (Membrane) product (Registration number: 国械注准20153641845) after receiving customer reports of suspected conjunctival hyperemia in patients using the product for postoperative anti-adhesion. The recall was formally reported on August 29, 2019, within the National Medical Products Administration (NMPA) regulatory framework.Upon receiving the reports, Beijing Bailikang immediately conducted an extensive internal investigation. This included a comprehensive review of raw materials, production processes, and finished product inspection records for the affected batch (BLK 1821). Additionally, irritation tests using animal models, including intravenous injection and eye drops, were performed in response to the reported symptoms. All internal and animal test results were reported as satisfactory, and the company stated no direct link was found between the reported issues and their products.Despite the lack of a proven link, the company proceeded with the recall in strict adherence to its quality management system and prevailing regulatory requirements, demonstrating a proactive commitment to patient safety. The required actions include sealing all 110 unsold units of the product and issuing recall notices to distributors, instructing them to cease sales and retrieve all remaining products from the market. Recalled items will be sealed and subsequently disposed of or destroyed following random inspection by the Beijing Municipal Food and Drug Administration.