# China NMPA Product Recall - Disposable medical masks

Source: https://www.globalkeysolutions.net/records/china_product_recall/shaoyang-qiankangyi-medical-equipment-co-ltd/1b465768-4d6c-4f92-ad0c-5900ca6d7f6c/
Source feed: China

> China NMPA product recall for Disposable medical masks by Shaoyang Qiankangyi Medical Equipment Co., Ltd. published November 23, 2020. Recall level: Level 3 Recall. Shaoyang Qiankangyi Medical Device Co., Ltd. has initiated a voluntary Level III recall of its dispo

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Shaoyang Qiankangyi Medical Device Co., Ltd. has voluntarily recalled disposable medical masks.
- Company Name: Shaoyang Qiankangyi Medical Equipment Co., Ltd.
- Publication Date: 2020-11-23
- Product Name: Disposable medical masks
- Recall Level: Level 3 Recall
- Recall Reason: During the sampling inspection of this batch of products, the ear loop tension and ventilation resistance did not meet the standard requirements.
- Discovering Company: Shaoyang Qiankangyi Medical Equipment Co., Ltd.
- Manufacturing Company: Shaoyang Qiankangyi Medical Equipment Co., Ltd.
- Summary: Shaoyang Qiankangyi Medical Device Co., Ltd. has initiated a voluntary Level III recall of its disposable medical masks, as reported by the National Medical Products Administration (NMPA) on November 23, 2020. The company’s decision, formally reported on October 26, 2020, stems from the production and sale of these medical devices that failed to adhere to their own registered product technical specifications. This non-compliance indicates a deviation from established quality and safety standards for medical devices, although specific inspection dates are not detailed in the report.The affected products, specifically disposable medical masks with registration certificate number 
20162640038, were distributed in regions including Shanxi. These masks are intended for use in medical settings to provide a physical barrier against pathogens during non-invasive procedures. The recall mechanism falls under the NMPA's regulatory framework, which mandates manufacturers to ensure their products consistently meet approved technical requirements throughout their lifecycle to protect public health.As a required action, Shaoyang Qiankangyi Medical Device Co., Ltd. is actively recalling the non-compliant masks from the market. A Level III recall signifies that while the product violation is unlikely to cause adverse health consequences, it still represents a significant deviation from regulatory standards. The company is responsible for ensuring the complete and effective removal of these products to uphold product safety and compliance.

Company: https://www.globalkeysolutions.net/companies/shaoyang-qiankangyi-medical-equipment-co-ltd/091207aa-8af3-471a-8ec8-28a49643ca3b/