# China NMPA Product Recall - Medical suture needles

Source: https://www.globalkeysolutions.net/records/china_product_recall/mani-co-ltdmani-incmani-co-ltd/96e69363-8715-44ee-b763-7e9a6bd18c00/
Source feed: China

> China NMPA product recall for Medical suture needles by Mani Co., Ltd./MANI, INC./Mani Co., Ltd. published December 05, 2016. Recall level: Level 3 Recall. MANI, INC. initiated a voluntary Class III recall of its medical sutures (registration number CFDA (

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: MANI, INC., Inc. is voluntarily recalling medical suture needles.
- Company Name: Mani Co., Ltd./MANI, INC./Mani Co., Ltd.
- Publication Date: 2016-12-05
- Product Name: Medical suture needles
- Recall Level: Level 3 Recall
- Recall Reason: The distributor affixed product labels to the original packaging, resulting in product labeling that did not comply with the requirements of the "Regulations on the Management of Instructions and Labels for Medical Devices" (Order No. 6 of the State Food and Drug Administration).
- Discovering Company: Mani (Beijing) Trading Co., Ltd.
- Manufacturing Company: Mani Co., Ltd./MANI, INC./Mani Co., Ltd.
- Summary: 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.

Company: https://www.globalkeysolutions.net/companies/mani-co-ltdmani-incmani-co-ltd/836ee1e7-74df-4528-b77f-fad49f45f55c/