# China NMPA Product Recall - Medical surgical masks

Source: https://www.globalkeysolutions.net/records/china_product_recall/guangdong-guokai-medical-equipment-co-ltd/391aa76a-90b0-4739-9692-47da26af7435/
Source feed: China

> China NMPA product recall for Medical surgical 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 its Medical Surg

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Guangdong Guokai Medical Device Co., Ltd. has voluntarily recalled disposable medical masks and medical surgical masks.
- Company Name: Guangdong Guokai Medical Equipment Co., Ltd.
- Publication Date: 2022-06-01
- Product Name: Medical surgical masks
- Recall Level: Level 3
- Recall Reason: During a random inspection by the Fujian Provincial Market Supervision Administration, the Fujian Provincial Medical Device Quality Supervision and Inspection Institute conducted an inspection. 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 inspection requirements. Therefore, the sample was deemed 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 its Medical Surgical Masks, as reported to the National Medical Products Administration (NMPA) on May 30, 2022, and publicly announced on June 1, 2022. The recall was prompted by a random inspection conducted by the Fujian Provincial Market Supervision Administration. During testing by the Fujian Provincial Medical Device Quality Supervision and Inspection Institute, samples from batch 20201212 (18,000 units) of the ear-loop type, non-sterile masks (17.5CM*9.5CM) were found to be non-compliant. Specifically, the breaking strength at the connection point of the mask strap and mask body was less than 10N, failing to meet established supervision and inspection standards. In response, Guangdong Guokai Medical Device Co., Ltd. undertook internal investigations, involving their Quality, Technical, and Production departments, to identify the root cause and implement corrective actions. Although the company decided to proceed with a recall, they reported a significant challenge: due to the high demand for epidemic prevention materials, the affected products had already been sold out by customers, making retrieval through a traditional recall process impractical. This situation highlights the complexities of product recalls for essential medical supplies during periods of high public health demand, even when non-compliance issues are identified.

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