# China NMPA Product Recall - Tungsten steel burs

Source: https://www.globalkeysolutions.net/records/china_product_recall/mani-co-ltdmani-incmani-co-ltd/80390e47-81e5-4c63-b971-94355dd8b47e/
Source feed: China

> China NMPA product recall for Tungsten steel burs by Mani Co., Ltd./MANI, INC./Mani Co., Ltd. published August 02, 2016. Recall level: Level 3 Recall. Mani (Beijing) Trading Co., Ltd. initiated a voluntary Class III recall of Tungsten Carbide Needles,

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: MANI, INC. is voluntarily recalling tungsten carbide sewing needles.
- Company Name: Mani Co., Ltd./MANI, INC./Mani Co., Ltd.
- Publication Date: 2016-08-02
- Product Name: Tungsten steel burs
- Recall Level: Level 3 Recall
- Recall Reason: The company's label approval process and production preparation caused delays in updating the old and new labels. The old labels were still used on products after March 30, 2015, and the production period was 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 (Beijing) Trading Co., Ltd. initiated a voluntary Class III recall of Tungsten Carbide Needles, a product manufactured by its parent company, MANI, INC. of Japan. The recall, published by the National Medical Products Administration (NMPA) on August 2, 2016, stemmed from self-inspection findings. The primary issues involved labeling discrepancies following a change in product registration information on March 30, 2015. Specifically, the company continued using outdated labels after this date due to delays in its label approval and production preparation processes. These labels also failed to include the production period on the Chinese versions. Furthermore, the agent's address on the labels was not promptly updated during the manufacturing period spanning March 30, 2015, to December 21, 2015. Consequently, Mani Co., Ltd. is undertaking this recall for all affected products, identified under Registration or Filing No.: CFDA (Imported) No. 20132550769. The recall aims to address these non-compliance issues and ensure accurate product information for consumers and regulatory bodies. Details on specific models, specifications, and batches are available in an accompanying Medical Device Recall List.

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