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

Source: https://www.globalkeysolutions.net/records/china_product_recall/dongguan-haokang-electronics-technology-co-ltd/a6f82bb2-eb23-4c61-a2a4-18b109f60a56/
Source feed: China

> China NMPA product recall for Arm-type fully automatic electronic blood pressure monitor by Dongguan Haokang Electronics Technology Co., Ltd. published May 31, 2022. Recall level: Level 3. Dongguan Haokang Electronics Technology Co., Ltd. has initiated a voluntary Level III recall for its

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Dongguan Haokang Electronics Technology Co., Ltd. is voluntarily recalling its arm-type fully automatic electronic blood pressure monitor.
- Company Name: Dongguan Haokang Electronics Technology Co., Ltd.
- Publication Date: 2022-05-31
- Product Name: Arm-type fully automatic electronic blood pressure monitor
- Recall Level: Level 3
- Recall Reason: The product instruction manual has not been updated in accordance with the 2020 edition of the "Regulations for the Management of Instructions and Labels for Medical Devices." This is primarily reflected in the fact that the registration certificate number in the instruction manual is still the old version, 20182200382, while the product registration certificate number is 国械注准20202070382. Furthermore, the sales and service telephone number has not been updated in the instruction manual in a timely manner.
- Discovering Company: Dongguan Haokang Electronics Technology Co., Ltd.
- Manufacturing Company: Dongguan Haokang Electronics Technology Co., Ltd.
- Summary: Dongguan Haokang Electronics Technology Co., Ltd. has initiated a voluntary Level III recall for its arm-type fully automatic electronic blood pressure monitors. This significant action, publicly announced on May 31, 2022, was reported via the Guangdong Provincial Drug Administration website, operating under the broader regulatory authority of China's National Medical Products Administration (NMPA).

The provided documentation does not specify any inspection dates or elaborate on the exact violations or issues that led to this recall. Instead, it refers to a "Medical Device Recall Event Report Form" for comprehensive details concerning the specific models, specifications, and batches of the affected products. As a Level III recall, it indicates that while a problem exists, the use of the product is unlikely to cause serious adverse health consequences. The main required action from the company is the immediate and voluntary withdrawal of these devices from the market. This incident highlights the regulatory framework established by the NMPA to monitor medical device safety and manufacturers' obligation to proactively manage and mitigate potential risks associated with their products.

Company: https://www.globalkeysolutions.net/companies/dongguan-haokang-electronics-technology-co-ltd/72dcc3aa-1f1e-40ff-995b-b99aaf6a8578/