# China NMPA Product Recall - Disposable medical masks

Source: https://www.globalkeysolutions.net/records/china_product_recall/guangdong-guokai-medical-equipment-co-ltd/fd608a10-a6a5-4c9e-bef4-df1cae900f78/
Source feed: China

> China NMPA product recall for Disposable medical masks by Guangdong Guokai Medical Equipment Co., Ltd. published June 01, 2022. Recall level: Level 3. Guangdong Guokai Medical Device Co., Ltd. initiated a voluntary Level III recall of 50,000 units of 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Guangdong Guokai Medical Device Co., Ltd. has voluntarily recalled disposable medical masks.
- Company Name: Guangdong Guokai Medical Equipment Co., Ltd.
- Publication Date: 2022-06-01
- Product Name: Disposable medical masks
- Recall Level: Level 3
- Recall Reason: During a random inspection by the Xinyu Municipal Market Supervision Administration in Jiangxi Province, the Xinyu Municipal Medical Device Quality Supervision and Inspection Institute of Jiangxi Province conducted tests. The results showed that, according to standards, the tensile strength at the connection point between the mask strap and the mask body was less than 10N, failing to meet the supervision and inspection standards. Therefore, the test conclusion was that the sample was unqualified.
- Discovering Company: Guangdong Guokai Medical Equipment Co., Ltd.
- Manufacturing Company: Guangdong Guokai Medical Equipment Co., Ltd.
- Summary: Guangdong Guokai Medical Device Co., Ltd. initiated a voluntary Level III recall of 50,000 units of its disposable medical masks following a deficiency identified during a random inspection. The National Medical Products Administration (NMPA) document, published on June 1, 2022, detailed the recall. An inspection by the Xinyu City Market Supervision Administration in Jiangxi Province, with testing by the Xinyu City Medical Device Quality Supervision and Inspection Institute, revealed that masks from batch number 20201220 failed quality standards. Specifically, the tensile strength at the connection point of the mask strap and body was found to be less than the required 10N, resulting in an unqualified product status.

The company responded by engaging its Quality, Technology, and Production departments to investigate and implement corrective actions, confirming the decision to recall the affected masks. However, a significant challenge was noted: due to the high demand for epidemic prevention materials during the pandemic, the entire batch of products had already been sold to customers. Consequently, the company stated that these items could not be effectively recalled, highlighting the complexities of product recovery in emergency supply chain scenarios under the NMPA's regulatory oversight.

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