# China NMPA Product Recall - Disposable medical masks

Source: https://www.keypedia.com/records/china_product_recall/xinxiang-jinhuan-medical-equipment-co-ltd/6092ce95-51b8-4137-a4ee-3dc03587bcf5
Source feed: China

> China NMPA product recall for Disposable medical masks by Xinxiang Jinhuan Medical Equipment Co., Ltd. published November 10, 2020. Recall level: Level 3 Recall. Xinxiang Jinhuan Medical Device Co., Ltd. initiated a voluntary Level III recall of 80,000 units of 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Xinxiang Jinhuan Medical Equipment Co., Ltd. has voluntarily recalled disposable medical masks.
- Company Name: Xinxiang Jinhuan Medical Equipment Co., Ltd.
- Publication Date: 2020-11-10
- Product Name: Disposable medical masks
- Recall Level: Level 3 Recall
- Recall Reason: The ventilation resistance did not meet the requirements. Provincial medical device spot checks found that the pressure difference was 53Pa, which is greater than the national standard of 49Pa, making it a substandard product.
- Discovering Company: Xinxiang Jinhuan Medical Equipment Co., Ltd.
- Manufacturing Company: Xinxiang Jinhuan Medical Equipment Co., Ltd.
- Summary: Xinxiang Jinhuan Medical Device Co., Ltd. initiated a voluntary Level III recall of 80,000 units of its disposable medical masks (Batch 020040613), effective November 10, 2020, under the oversight of China's National Medical Products Administration (NMPA). The recall was prompted by a provincial medical device sampling inspection that identified the masks as non-compliant with ventilation resistance standards. Specifically, the masks exhibited a pressure difference of 53Pa, exceeding the national regulatory limit of 49Pa, rendering them substandard. The company's investigation revealed that all 78,000 units distributed within China from the affected batch had already been consumed by customers, with no remaining inventory to retrieve. As a corrective action, Xinxiang Jinhuan Medical Device Co., Ltd. committed to addressing the root cause of the non-compliance. The company suspects the issue stemmed from using BFE99 grade meltblown fabric instead of the BFE95 grade, which had previously yielded compliant test results. Subsequent production will utilize the BFE95 grade fabric to ensure adherence to national quality and safety standards. This recall highlights the importance of rigorous quality control in medical device manufacturing.

Company: https://www.keypedia.com/companies/xinxiang-jinhuan-medical-equipment-co-ltd/826f6d89-6d9d-4f01-b078-bbb320b4658a