China NMPA Product Recall - Artificial nasolacrimal duct

Hunan Huafu Medical Device Technology Co., Ltd. initiated a voluntary Class III recall of its Artificial Nasolacrimal Tubes (Registration No.: 湘械注准20172660081), as reported to the Hunan Provincial Food and Drug Administration on August 1, 2017, and publicly announced by the National Medical Products Administration (NMPA) on August 7, 2017. The recall was prompted by a critical compliance issue: the company failed to timely update its production license number on product packaging labels and instruction manuals, following a change in its production license. This deficiency specifically impacted batch number 170110, involving 709 units of the medical device intended for treating nasolacrimal duct obstruction, with 698 units sold within China. Operating under the regulatory framework that governs medical device recalls, the company is required to correct this labeling discrepancy. As a required action, Hunan Huafu Medical Device Technology Co., Ltd. committed to amending the production license information on all affected product packaging and instruction manuals. This corrective measure aims to ensure that all product information accurately reflects current regulatory approvals and maintains consumer confidence in the medical device.