# 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/f6a0163b-1252-42f6-ab3b-00f43293dc8f/
Source feed: China

> China NMPA product recall for Arm-type fully automatic electronic blood pressure monitor by Fudakang Industrial Co Ltd published August 14, 2019. Recall level: Level 3. Dongguan Fudakang Industrial Co., Ltd. has initiated a voluntary, Level III recall for 150 units of 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Dongguan Fudakang Industrial Co., Ltd. is voluntarily recalling its arm-type fully automatic electronic blood pressure monitors.
- Company Name: Fudakang Industrial Co Ltd
- Publication Date: 2019-08-14
- Product Name: Arm-type fully automatic electronic blood pressure monitor
- Recall Level: Level 3
- Recall Reason: The outer packaging does not comply with the requirements of 4.2.2 in YY0670-2008 and the instruction manual does not comply with the requirements of 4.2.3 d) in YY0670-2008-1. These two non-compliances are only errors in labeling information and do not involve product safety and effectiveness. In order to ensure compliance with regulatory requirements, our company has decided to voluntarily recall the product.
- Discovering Company: Dongguan Fudakang Industrial Co., Ltd.
- Manufacturing Company: Fudakang Industrial Co Ltd
- Summary: Dongguan Fudakang Industrial Co., Ltd. has initiated a voluntary, Level III recall for 150 units of its arm-type fully automatic electronic blood pressure monitors, specifically model FT-A11-2, batch 1505. This recall, affecting products sold in China, was reported to the National Medical Products Administration (NMPA) on August 14, 2019. The basis for this action stemmed from an inspection report, dated August 7, 2019, issued by the Shanghai Medical Device Inspection Institute. The report identified non-compliance regarding the product's packaging and instruction manuals. Specifically, these components did not meet the requirements of standard YY0670-2008, sections 4.2.2 and 4.2.3, respectively, due to incorrect labeling information. It was explicitly stated by the company that these issues were related solely to labeling and did not compromise the product's safety or effectiveness. To address these regulatory discrepancies, Dongguan Fudakang Industrial Co., Ltd. is undertaking corrective actions. These include supplementing the recalled product packaging and instruction manuals with the necessary information to ensure full adherence to the YY0670-2008 standard. This proactive measure highlights the company's commitment to maintaining regulatory compliance and product integrity under the NMPA framework.

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