# China NMPA Product Recall - Artificial nasolacrimal duct

Source: https://www.globalkeysolutions.net/records/china_product_recall/hunan-huafu-medical-device-technology-co-ltd/d3394121-1d88-4ea4-b109-98366777c6f8/
Source feed: China

> China NMPA product recall for Artificial nasolacrimal duct by Hunan Huafu Medical Device Technology Co., Ltd. published August 02, 2017. Recall level: Level 3 Recall. Hunan Huafu Medical Device Technology Co., Ltd. initiated a voluntary Class III recall of its artifi

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Hunan Huafu Medical Device Technology Co., Ltd. voluntarily recalls artificial nasolacrimal ducts
- Company Name: Hunan Huafu Medical Device Technology Co., Ltd.
- Publication Date: 2017-08-02
- Product Name: Artificial nasolacrimal duct
- Recall Level: Level 3 Recall
- Recall Reason: Product packaging relabeling: Due to a change in the production license, the production license number could not be updated on the packaging labels and instructions for this batch of products.
- Discovering Company: Hunan Huafu Medical Device Technology Co., Ltd.
- Manufacturing Company: Hunan Huafu Medical Device Technology Co., Ltd.
- Summary: Hunan Huafu Medical Device Technology Co., Ltd. initiated a voluntary Class III recall of its artificial nasolacrimal ducts (Registration No.: 
20172660081), as reported to the Hunan Provincial Food and Drug Administration on August 1, 2017, and published by the National Medical Products Administration (NMPA) on August 2, 2017. The recall affects batch number 170110, comprising 709 units, with 698 units sold within China. The primary reason for the recall was a documentation and labeling discrepancy; the product packaging labels and instructions failed to reflect an updated production license number following a change in the company's manufacturing license. This issue pertains to administrative compliance rather than product safety or efficacy. Under the NMPA's regulatory framework for medical device recalls, a Class III recall indicates that using or exposing to the product is unlikely to cause adverse health consequences. The company's required action involves retrieving the affected products from the market to correct the labeling and ensure full regulatory compliance. This voluntary action demonstrates the company's commitment to adhering to national medical device standards and maintaining accurate product information for consumers and healthcare providers.

Company: https://www.globalkeysolutions.net/companies/hunan-huafu-medical-device-technology-co-ltd/0520e327-0fbf-4b35-9ef9-a18daf206e2a/