# China NMPA Product Recall - Medical surgical masks

Source: https://www.globalkeysolutions.net/records/china_product_recall/yixin-medical-devices-co-ltd/38a13ea4-2983-451e-ac20-d64beb515868/
Source feed: China

> China NMPA product recall for Medical surgical masks by Yixin Medical Devices Co., Ltd. published November 10, 2020. Recall level: Level 3. Yixin Medical Devices Co., Ltd. issued a voluntary Class III recall for a specific batch of its medi

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Yixin Medical Devices Co., Ltd. voluntarily recalls medical surgical masks
- Company Name: Yixin Medical Devices Co., Ltd.
- Publication Date: 2020-11-10
- Product Name: Medical surgical masks
- Recall Level: Level 3
- Recall Reason: The mask strap failed the breaking strength test.
- Discovering Company: Yixin Medical Devices Co., Ltd.
- Manufacturing Company: Yixin Medical Devices Co., Ltd.
- Summary: Yixin Medical Devices Co., Ltd. issued a voluntary Class III recall for a specific batch of its medical surgical masks, identified by batch number 200325616. This action, reported on November 2, 2020, and subsequently publicized by the National Medical Products Administration (NMPA) on November 10, 2020, was prompted by a critical product quality issue: the mask straps failed to meet the required tensile strength specifications, indicating a substandard breakage strength. The affected batch comprised 16,000 units, which were distributed and utilized in the regions of Hubei and Guangxi, China. These masks are designed to provide essential protection for medical personnel, safeguarding against bodily fluids and splashes during medical procedures. Upon discovering the non-compliance, Yixin Medical Devices Co., Ltd. promptly initiated corrective measures by recalling all units from the identified batch. However, the company reported that all 16,000 affected masks had already been used by the time of the recall. Importantly, the company confirmed that no adverse reactions or injuries were reported in connection with the substandard masks. This recall underscores the rigorous quality control and safety standards enforced by the NMPA within the medical device industry.

Company: https://www.globalkeysolutions.net/companies/yixin-medical-devices-co-ltd/8eacb3b1-c0d5-40ce-b1d4-f165ae0ff001/