# China NMPA Product Recall - Disposable medical surgical masks

Source: https://www.globalkeysolutions.net/records/china_product_recall/guangdong-guokai-medical-equipment-co-ltd/f387d6fd-1f63-44c5-887c-01eb3bde442b/
Source feed: China

> China NMPA product recall for Disposable medical surgical masks by Guangdong Guokai Medical Equipment Co., Ltd. published March 18, 2022. Recall level: Level 3. Guangdong Ruihua Medical Device Co., Ltd. initiated a voluntary Class III recall of its disposable m

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Guangdong Ruihua Medical Device Co., Ltd. has voluntarily recalled disposable medical surgical masks.
- Company Name: Guangdong Guokai Medical Equipment Co., Ltd.
- Publication Date: 2022-03-18
- Product Name: Disposable medical surgical masks
- Recall Level: Level 3
- Recall Reason: Random inspections revealed that the products did not meet the required standards.
- Discovering Company: Guangdong Ruihua Medical Equipment Co., Ltd.
- Manufacturing Company: Guangdong Guokai Medical Equipment Co., Ltd.
- Summary: Guangdong Ruihua Medical Device Co., Ltd. initiated a voluntary Class III recall of its disposable medical surgical masks, specifically from production batch number 20201206. The recall was announced on March 18, 2022, by the National Medical Products Administration (NMPA) through its Guangdong Provincial Drug Administration website. The affected masks hold Registration Certificate No.: 
粤械注准20202141273. While the document specifies the product and batch under recall, the precise nature or specific violation prompting the action is not detailed, beyond it being a voluntary measure by the company. Further comprehensive information regarding the recall event, including detailed product specifics and the rationale behind the action, is referenced as being available in an attached "Medical Device Recall Event Report Form," which was not provided in the excerpt. This action falls under the regulatory oversight of the NMPA, China's primary authority for medical device regulation.

Company: https://www.globalkeysolutions.net/companies/guangdong-guokai-medical-equipment-co-ltd/d3c10889-2f7c-48e1-b6bd-8243656e5459/