China NMPA Product Recall - Medical suture needles

MANI, INC., a Japanese manufacturer, and its Chinese subsidiary, MANI (Beijing) Trading Co., Ltd., initiated a voluntary Class III recall of its medical suture needles (CFDA (Imported) No. 20142011066). The recall, reported on November 28, 2016, and published on December 5, 2016, was prompted by a market sales management discovery. Distributors had affixed new product labels directly over the original packaging, which was identified as a non-compliance with China's "Regulations on the Management of Instructions and Labels for Medical Devices" (State Food and Drug Administration Order No. 6). The company emphasized that this labeling error had no adverse effect on the product's normal use, but acknowledged the importance of providing accurate information and upholding social responsibility. Approximately 3000 packs of affected products were imported and sold in China. In response, MANI (Beijing) Trading Co., Ltd. is collecting and disposing of all recalled items. MANI, INC. in Japan has committed to strengthening its management of distributors. It has temporarily suspended the implicated distributor's sales rights for MANI brand products in mainland China. Additionally, existing stock with distributors is being quarantined and shipments frozen. Customers who have received affected products will be informed through notification letters dispatched via distributors.