# China NMPA Product Recall - Small medical oxygen concentrator

Source: https://www.globalkeysolutions.net/records/china_product_recall/foshan-care-medical-technology-co-ltd/3b22d260-7359-4acc-a5bb-e4c816bae7b6/
Source feed: China

> China NMPA product recall for Small medical oxygen concentrator by FOSHAN CARE MEDICAL TECHNOLOGY CO., LTD. published September 19, 2020. Recall level: Level 3 Recall. Foshan Kaiya Medical Technology Co., Ltd. initiated a voluntary Level III recall for its small medic

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Foshan Kaiya Medical Technology Co., Ltd. has voluntarily recalled its small medical oxygen concentrators.
- Company Name: FOSHAN CARE MEDICAL TECHNOLOGY CO., LTD.
- Publication Date: 2020-09-19
- Product Name: Small medical oxygen concentrator
- Recall Level: Level 3 Recall
- Discovering Company: Foshan Kaiya Medical Technology Co., Ltd.
- Manufacturing Company: FOSHAN CARE MEDICAL TECHNOLOGY CO., LTD.
- Summary: Foshan Kaiya Medical Technology Co., Ltd. initiated a voluntary Level III recall for its small medical oxygen concentrators, as announced by the National Medical Products Administration (NMPA) and the Guangdong Provincial Drug Administration on September 19, 2020. This proactive measure by the company addresses potential product concerns. While the specific issues or manufacturing deviations prompting the recall are not detailed in the public notice, a 'Recall Event Report Form' is referenced for comprehensive information regarding affected models, specifications, and batch numbers. A Level III recall generally indicates that the product's use is unlikely to cause adverse health consequences, but a deviation from established quality or regulatory standards has been identified. This action underscores the continuous regulatory oversight by the NMPA, which is mandated to ensure the safety and efficacy of medical devices in China. Companies are expected to maintain stringent quality control and report any discrepancies that might affect product performance or patient safety, leading to measures like this voluntary recall to mitigate potential market risks.

Company: https://www.globalkeysolutions.net/companies/foshan-care-medical-technology-co-ltd/f229ec04-831d-4d82-b69c-3859e58cda32/