China NMPA Product Recall - Artificial nasolacrimal duct

Hunan Huafu Medical Device Technology Co., Ltd. initiated a voluntary Class III recall for its Artificial Nasolacrimal Tubes (Registration No.: 湘械注准20172660081). The recall, reported on August 1, 2017, and published by the National Medical Products Administration (NMPA) on August 7, 2017, was prompted by a critical labeling non-conformance. The company failed to promptly update the production license number on the product packaging labels and instructions after a change in its production license. This oversight meant that the labeling for the affected products, specifically batch number 170110, comprising 709 units (with 698 units sold), contained outdated regulatory information. These Artificial Nasolacrimal Tubes, designed for treating nasolacrimal duct obstruction, were distributed within China. The regulatory framework overseeing this recall includes the NMPA and the Hunan Provincial Food and Drug Administration. As a required action, the company is undertaking the recall of the identified product batch. Additionally, corrective measures necessitate that Hunan Huafu Medical Device Technology Co., Ltd. revise all product packaging labels and instructions to accurately display the current production license information, thereby ensuring full compliance with prevailing NMPA standards and regulations.