# China NMPA Product Recall - Disposable concentric circular needle electrode

Source: https://www.globalkeysolutions.net/records/china_product_recall/natus-manufacturing-limited/035ae7c8-2c79-49de-bdd8-3190fe84ec32/
Source feed: China

> China NMPA product recall for Disposable concentric circular needle electrode by Natus Manufacturing Limited published June 21, 2017. Recall level: Level 3 Recall. Natus Manufacturing Limited, in conjunction with its agent Natus Medical Instruments (Beijing) Co., 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Natus Manufacturing Limited is voluntarily recalling disposable concentric circular needle electrodes.
- Company Name: Natus Manufacturing Limited
- Publication Date: 2017-06-21
- Product Name: Disposable concentric circular needle electrode
- Recall Level: Level 3 Recall
- Recall Reason: The products sold to China do not comply with the CFDA's "Regulations on the Administration and Management of Medical Device Instructions and Labels" (Order No. 6), and do not include product instructions and labels approved by the China Food and Drug Administration. Since the product instructions and labels that meet the CFDA requirements have not yet been released when this batch of products was released, it is inferred that this batch of products does not meet the CFDA's import requirements. Therefore, a voluntary recall was initiated to correct the situation.
- Discovering Company: NITES Medical Instruments (Beijing) Co., Ltd.
- Manufacturing Company: Natus Manufacturing Limited
- Summary: Natus Manufacturing Limited, in conjunction with its agent Natus Medical Instruments (Beijing) Co., Ltd., initiated a voluntary Class III recall of its disposable concentric circular needle electrodes in China. This recall, reported on June 14, 2017, and subsequently published by the National Medical Products Administration (NMPA) on June 21, 2017, addresses a significant regulatory compliance issue. The main violation identified was that the products sold in China lacked the required instructions and labels approved by the China Food and Drug Administration (CFDA). Specifically, these materials did not conform to the CFDA's "Regulations on the Administration and Management of Medical Device Instructions for Use" (Order No. 6), which outlines essential documentation requirements for imported medical devices. The affected products, identified by model 53156 and specific batch numbers such as 05A/17/T and 05B/17/T, totaled 319 units distributed within China. As the compliant documentation had not been released at the time of the products' distribution, they failed to meet the CFDA's import criteria. To rectify this, Natus Manufacturing Limited is requiring the return of all impacted units to its manufacturing facility in Ireland. This action underscores the company's commitment to ensuring all products meet the stringent regulatory standards governing medical devices in the Chinese market, prioritizing adherence to documentation mandates.

Company: https://www.globalkeysolutions.net/companies/natus-manufacturing-limited/7385345d-6b36-4dc3-ab9e-376bfae4667d/