# China NMPA Product Recall - Arm-type fully automatic electronic blood pressure monitor

Source: https://www.globalkeysolutions.net/records/china_product_recall/fudakang-industrial-co-ltd/1ce4fda6-06f2-45c3-bab8-16cb31d7b672/
Source feed: China

> China NMPA product recall for Arm-type fully automatic electronic blood pressure monitor by Fudakang Industrial Co Ltd published May 30, 2022. Recall level: Level 3 Recall. Dongguan Fudakang Industrial Co., Ltd. has initiated a voluntary Class III recall of its manufacture

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Dongguan Fudakang Industrial Co., Ltd. has initiated a voluntary recall of its medical arm-type fully automatic electronic blood pressure monitor.
- Company Name: Fudakang Industrial Co Ltd
- Publication Date: 2022-05-30
- Product Name: Arm-type fully automatic electronic blood pressure monitor
- Recall Level: Level 3 Recall
- Discovering Company: Dongguan Fudakang Industrial Co., Ltd.
- Manufacturing Company: Fudakang Industrial Co Ltd
- Summary: Dongguan Fudakang Industrial Co., Ltd. has initiated a voluntary Class III recall of its manufactured medical arm-type fully automatic electronic blood pressure monitors. This action was publicly reported on May 30, 2022, under the oversight of the National Medical Products Administration (NMPA) of China, with the announcement disseminated via the Guangdong Provincial Drug Administration Website. The primary issue prompting this recall is the identified necessity for the company to retrieve these specific medical devices from the market. While the official document confirms the voluntary nature and the Class III designation of the recall, it does not detail the specific violations or underlying safety concerns that led to this decision. Information regarding precise product models, specifications, and affected batches is referenced as available in an associated "Medical Device Recall Event Report Form," which was not provided in the public notice. As this is a company-initiated voluntary recall, the document does not mention any specific inspection dates. The regulatory framework governing this action is the NMPA, which is responsible for safeguarding public health by ensuring the safety and efficacy of medical products in China. The required action is the ongoing removal of the identified blood pressure monitors from circulation, underscoring the company's commitment to compliance with national medical device regulations.

Company: https://www.globalkeysolutions.net/companies/fudakang-industrial-co-ltd/e3dfcf55-4946-43fb-9612-d0c5185e06dc/