China NMPA Product Recall - Medical suture needles

MANI, INC. initiated a voluntary Class III recall of its medical sutures (registration number CFDA (Imported) No. 20142011066) on December 5, 2016. The recall was prompted by MANI (Beijing) Trading Co., Ltd.'s discovery during its market sales management that distributors had incorrectly affixed product labels over the original packaging labels. This practice constituted a violation of the labeling requirements stipulated in the 'Regulations on the Management of Instructions and Labels for Medical Devices' (Order No. 6 of the State Food and Drug Administration), which governs the management of medical device instructions and labels in China. The core issue revolved around non-compliant labeling, where supplementary labels were placed in a manner that did not adhere to regulatory standards for medical device packaging. As a corrective action, MANI, INC. voluntarily undertook this recall to address the non-conforming products. Details concerning the specific affected product models, specifications, and batch numbers were made available in an attached Medical Device Recall Event Report Form. This action underscores the company's commitment to compliance with national medical product administration standards.