# China NMPA Product Recall - Tungsten steel burs

Source: https://www.globalkeysolutions.net/records/china_product_recall/mani-co-ltdmani-incmani-co-ltd/6834a77c-05bf-47be-88b7-37c6bc337ee1/
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, INC. of Japan and its Chinese subsidiary, Mani (Beijing) Trading Co., Ltd., initiated a Class 

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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: During its self-inspection, Mani (Beijing) Trading Co., Ltd. discovered that for tungsten carbide needles shipped to China by Mani Co., Ltd. of Japan, after obtaining a change in the agent's address registration information on March 30, 2015, the company's label approval process and production preparation caused delays in updating the old and new labels. As a result, the products continued to use the old labels after March 30, 2015, and 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 and its Chinese subsidiary, Mani (Beijing) Trading Co., Ltd., initiated a Class III voluntary recall of Tungsten Carbide Needles (Registration No.: CFDA (Imported) No. 20132550769) following a self-inspection. The recall stems from labeling non-compliance for products manufactured between March 30, 2015, and December 21, 2015. The primary violations include delays in updating labels after a change in the agent's registered address, continued use of outdated labels, and the omission of production and expiration dates on Chinese labels. These issues contravene the National Medical Products Administration's "Regulations on the Management of Medical Device Instructions and Labels" (Order No. 6) and SFDA [2014] No. 144. Although the product's 15-year shelf life means the labeling errors do not affect product use, required actions include freezing undelivered shipments until labels are corrected, producing new compliant labels for future exports to China, isolating and relabeling existing inventory at the agent's location, and notifying affected customers about the discrepancies.

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