# China NMPA Product Recall - Cerebral hemodynamic monitoring device

Source: https://www.globalkeysolutions.net/records/china_product_recall/shanghai-pucui-biotechnology-co-ltd/22b45a91-1936-44dc-b105-df924bec56b7/
Source feed: China

> China NMPA product recall for Cerebral hemodynamic monitoring device by Shanghai Pucui Biotechnology Co., Ltd. published November 23, 2021. Recall level: Level 3 Recall. On November 23, 2021, the National Medical Products Administration (NMPA) announced a voluntary Clas

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Shanghai Shicai Biotechnology Co., Ltd. is voluntarily recalling its cerebral vascular hemodynamic monitoring device.
- Company Name: Shanghai Pucui Biotechnology Co., Ltd.
- Publication Date: 2021-11-23
- Product Name: Cerebral hemodynamic monitoring device
- Recall Level: Level 3 Recall
- Recall Reason: The issues involve products whose performance and composition have not changed. However, after the product's registration was renewed, the medical device production product registration form on the medical device production license was not updated in a timely manner.
- Discovering Company: Shanghai Shicai Biotechnology Co., Ltd.
- Manufacturing Company: Shanghai Pucui Biotechnology Co., Ltd.
- Summary: On November 23, 2021, the National Medical Products Administration (NMPA) announced a voluntary Class III recall initiated by Shanghai Shicai Biotechnology Co., Ltd. This action pertains to their cerebral vascular hemodynamics monitor, identified by Registration Certificate No. 沪械注准20192070399.

The primary issues prompting this recall include concerns regarding the product's performance and composition. More critically, the company failed to promptly update the Medical Device Production Product Registration Form on its Medical Device Production License following the product's renewal registration. This oversight signifies a lapse in regulatory compliance, as accurate and up-to-date documentation is essential for medical device manufacturing and registration under the NMPA's regulatory framework.

As a required action, Shanghai Shicai Biotechnology Co., Ltd. is voluntarily recalling affected units of the cerebral vascular hemodynamics monitor. Further details regarding specific product models, specifications, and batch numbers are available in the accompanying "Medical Device Recall Event Report Form." This action underscores the importance of stringent adherence to regulatory documentation requirements to ensure product safety and compliance within the medical device industry.

Company: https://www.globalkeysolutions.net/companies/shanghai-pucui-biotechnology-co-ltd/fc3c45bc-4772-4254-8a04-3e7511fec85a/