# China NMPA Product Recall - Disposable concentric circular needle electrode

Source: https://www.globalkeysolutions.net/records/china_product_recall/natus-manufacturing-limited/d1dc063a-76b6-4546-9e3a-39f684b8e923/
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 cooperation with its Chinese agent Natus Medical Instruments (Beijin

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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 for Use, Labels and Documentation" (Order No. 6). They do not include product instructions and labels approved by the China Food and Drug Administration. Since compliant product instructions and labels were not yet released when this batch of products was released, it is inferred that this batch of products does not meet CFDA import requirements.
- Discovering Company: NITES Medical Instruments (Beijing) Co., Ltd.
- Manufacturing Company: Natus Manufacturing Limited
- Summary: Natus Manufacturing Limited, in cooperation with its Chinese agent Natus Medical Instruments (Beijing) Co., Ltd., initiated a voluntary Level III recall for its Disposable Concentric Circular Needle Electrodes. This recall, reported on June 14, 2017, addresses a significant compliance issue affecting 319 units across various batches, including 05A/17/T and 05B/17/T, distributed within China. These electrodes are critical for electromyography (EMG) and evoked nerve signal stimulation/recording. The core violation stemmed from the products' non-adherence to the China Food and Drug Administration (CFDA) regulatory framework, specifically the "Regulations on the Administration and Management of Medical Device Instructions for Use" (Order No. 6). Crucially, the affected devices lacked CFDA-approved product instructions and labels at the time of their release and sale in China. This omission meant the products did not meet the mandatory import requirements set by the CFDA. As a required action, Natus Manufacturing Limited is orchestrating the return of all impacted products to its manufacturing facility in Ireland. There, comprehensive corrective actions will be undertaken to ensure future compliance. This proactive measure by the company underscores its commitment to rectifying regulatory discrepancies and upholding product safety and proper documentation standards in the Chinese market.

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