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

Source: https://www.globalkeysolutions.net/records/china_product_recall/beijing-bailikang-biochemical-co-ltd/13583d84-0308-4560-8248-69418550f053/
Source feed: China

> China NMPA product recall for Medical-grade anti-adhesion modified chitosan (membrane) by Beijing Bailikang Biochemical Co., Ltd. published September 02, 2019. Recall level: Level 3. Beijing Bailikang Biochemical Co., Ltd. initiated a Class III voluntary recall of its Medical-Grade 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Beijing Bailikang Biochemical Co., Ltd. is voluntarily recalling its medical-grade anti-adhesion modified chitosan (membrane).
- Company Name: Beijing Bailikang Biochemical Co., Ltd.
- Publication Date: 2019-09-02
- Product Name: Medical-grade anti-adhesion modified chitosan (membrane)
- Recall Level: Level 3
- Recall Reason: Recently, some customers have reported suspected conjunctival hyperemia issues with our company's products used for postoperative anti-adhesion. The company immediately conducted an investigation and assessment of the product defects. Following the product technical requirements, the company reviewed all factory inspection items, as well as the raw materials used in this batch of products, the production process, production process inspection, and finished product inspection records. Furthermore, in response to the conjunctival hyperemia symptoms, animal intravenous injection and eye drop stimulation tests were added, and all test results were satisfactory. Currently, no direct link has been found between this incident and our product. However, in strict accordance with our quality management system and regulatory requirements, our company has decided to proactively recall this batch of products.
- Discovering Company: Beijing Bailikang Biochemical Co., Ltd.
- Manufacturing Company: Beijing Bailikang Biochemical Co., Ltd.
- Summary: 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.

Company: https://www.globalkeysolutions.net/companies/beijing-bailikang-biochemical-co-ltd/3d797665-892e-4afa-85a9-d6b83ca55266/