# China NMPA Product Recall - Disposable masks

Source: https://www.globalkeysolutions.net/records/china_product_recall/changshu-yinuo-medical-supplies-co-ltd/253aa3e2-22a2-4947-aa94-a0fec473c556/
Source feed: China

> China NMPA product recall for Disposable masks by Changshu Yinuo Medical Supplies Co., Ltd. published December 31, 2019. Recall level: Level 3 Recall. Changshu Yinuo Medical Supplies Co., Ltd. has initiated a voluntary Level III recall for its disposa

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Changshu Yinuo Medical Supplies Co., Ltd. voluntarily recalls disposable masks
- Company Name: Changshu Yinuo Medical Supplies Co., Ltd.
- Publication Date: 2019-12-31
- Product Name: Disposable masks
- Recall Level: Level 3 Recall
- Recall Reason: In the 2019 national medical device spot check, the elastic band failed to meet the standard requirements for tensile strength.
- Discovering Company: Changshu Yinuo Medical Supplies Co., Ltd.
- Manufacturing Company: Changshu Yinuo Medical Supplies Co., Ltd.
- Summary: Changshu Yinuo Medical Supplies Co., Ltd. has initiated a voluntary Level III recall for its disposable absorbent masks. This action follows findings from a 2019 national medical device spot check conducted under the oversight of the National Medical Products Administration (NMPA). The primary issue identified during the inspection was that the elastic bands on the disposable masks failed to meet the specified standard requirements for elasticity. This non-compliance prompted the company to take immediate corrective measures. The recall specifically targets disposable absorbent masks, identified by Code: Su Medical Device Registration Certificate 20172640236. While specific inspection dates are not detailed, the issue was detected during the 2019 national medical device spot check. As a result, Changshu Yinuo Medical Supplies Co., Ltd. is actively withdrawing the affected products from the market. The recall, classified as Level III, signifies that the product defect is unlikely to cause adverse health consequences but still warrants corrective action to ensure adherence to quality and safety standards. Comprehensive information regarding the models, specifications, and batch numbers of the recalled products is documented in the company's "Medical Device Recall Event Report Form," which is available for public review.

Company: https://www.globalkeysolutions.net/companies/changshu-yinuo-medical-supplies-co-ltd/a64b665a-b9da-4396-a3fb-8117c6ee9e72/