# China NMPA Product Recall - Disposable medical masks

Source: https://www.globalkeysolutions.net/records/china_product_recall/guangdong-nicole-apparel-co-ltd/224bd88d-d3e3-4e12-a0de-edc77d2e3ea0/
Source feed: China

> China NMPA product recall for Disposable medical masks by Guangdong Nicole Apparel Co., Ltd. published June 01, 2022. Recall level: Level 3. Guangdong Nicole Apparel Co., Ltd. initiated a voluntary Level III recall of its disposable medical 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Guangdong Nicole Apparel Co., Ltd. has voluntarily recalled disposable medical masks.
- Company Name: Guangdong Nicole Apparel Co., Ltd.
- Publication Date: 2022-06-01
- Product Name: Disposable medical masks
- Recall Level: Level 3
- Recall Reason: During a random inspection by the Zhanjiang Municipal Market Supervision and Administration Bureau, the sample was tested by the Guangdong Provincial Medical Device Quality Supervision and Inspection Institute. The test 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 and the air resistance was greater than 49Pa/cm², failing to meet the supervision and inspection requirements. Therefore, the test conclusion was that the sample was unqualified.
- Discovering Company: Guangdong Nicole Apparel Co., Ltd.
- Manufacturing Company: Guangdong Nicole Apparel Co., Ltd.
- Summary: Guangdong Nicole Apparel Co., Ltd. initiated a voluntary Level III recall of its disposable medical masks, as reported to the National Medical Products Administration (NMPA) on May 30, 2022. This action followed a random inspection by the Zhanjiang Municipal Market Supervision Administration, where the Guangdong Provincial Medical Device Quality Supervision and Inspection Institute found the masks to be non-compliant with quality standards. The primary violations identified were insufficient tensile strength at the mask strap connection point, which was less than the required 10N, and excessive ventilation resistance, exceeding 49Pa/cm². These deficiencies rendered the product unqualified, posing potential concerns regarding performance and safety. In response, Guangdong Nicole Apparel Co., Ltd. promptly engaged its Quality, Technical, and Production Departments to research and implement corrective actions. The affected batch, identified as 20200918, comprised 48,000 units of ear-loop type (non-sterile) masks. However, the company noted that due to high demand for epidemic prevention materials, all affected products had already been sold by customers and could not be retrieved. This recall demonstrates the NMPA's framework for ensuring medical device quality and manufacturers' responsibility in addressing product non-conformities.

Company: https://www.globalkeysolutions.net/companies/guangdong-nicole-apparel-co-ltd/94178c94-ab1c-4cb4-ad7c-f2eb75899e76/