# China NMPA Product Recall - Tungsten steel burs

Source: https://www.globalkeysolutions.net/records/china_product_recall/mani-co-ltdmani-incmani-co-ltd/1f193511-2725-4096-92ff-027cdb399ea1/
Source feed: China

> China NMPA product recall for Tungsten steel burs by Mani Co., Ltd./MANI, INC./Mani Co., Ltd. published August 30, 2016. Recall level: Level 3. MANI, INC. of Japan, in collaboration with its Chinese subsidiary Mani (Beijing) Trading Co., Ltd., 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: MANI, INC., Inc. is voluntarily recalling tungsten carbide sewing needles.
- Company Name: Mani Co., Ltd./MANI, INC./Mani Co., Ltd.
- Publication Date: 2016-08-30
- Product Name: Tungsten steel burs
- Recall Level: Level 3
- Recall Reason: Due to delays in the company's label approval process and production preparation, the old labels were still used on products after March 30, 2015. The production date and expiration date were not indicated on the Chinese labels of the products. In addition, the agent's address on the labels was not updated in a timely manner during the production period from March 30, 2015 to December 21, 2015.
- Discovering Company: Mani (Beijing) Trading Co., Ltd.
- Manufacturing Company: Mani Co., Ltd./MANI, INC./Mani Co., Ltd.
- Summary: MANI, INC. of Japan, in collaboration with its Chinese subsidiary Mani (Beijing) Trading Co., Ltd., initiated a voluntary Level III recall for 104,843 boxes of Tungsten Carbide Needles. This recall, reported on August 30, 2016, followed a self-inspection that identified several labeling non-compliance issues for products produced or imported between March 30, 2015, and December 21, 2015. The main violations included the continued use of old labels after a registration information change, the omission of production and expiration dates on Chinese labels, and the failure to promptly update the agent's address on the labels. These issues violated China's "Regulations on the Management of Instructions and Labels for Medical Devices" (SFDA Order No. 6) and other relevant regulatory notices. As required actions, MANI, INC. has ceased shipments of non-compliant products, committed to producing and affixing new, compliant labels for all future exports to China, and will assist distributors in isolating and relabeling existing inventory. Affected customers are being notified through their distributors regarding the labeling discrepancies.

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