# China NMPA Product Recall - Disposable masks

Source: https://www.globalkeysolutions.net/records/china_product_recall/xinxiang-jinhuan-medical-equipment-co-ltd/9a5a7c67-4324-45fe-a015-34a6370924e8/
Source feed: China

> China NMPA product recall for Disposable masks by Xinxiang Jinhuan Medical Equipment Co., Ltd. published December 16, 2019. Recall level: Level 3. Xinxiang Changda Medical Device Co., Ltd. initiated a voluntary Class III recall of its disposable m

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Xinxiang Changda Medical Equipment Co., Ltd. has voluntarily recalled disposable masks.
- Company Name: Xinxiang Jinhuan Medical Equipment Co., Ltd.
- Publication Date: 2019-12-16
- Product Name: Disposable masks
- Recall Level: Level 3
- Recall Reason: The breaking strength test at the connection point of the mask body failed.
- Discovering Company: Xinxiang Changda Medical Equipment Co., Ltd.
- Manufacturing Company: Xinxiang Jinhuan Medical Equipment Co., Ltd.
- Summary: Xinxiang Changda Medical Device Co., Ltd. initiated a voluntary Class III recall of its disposable masks, as reported to the National Medical Products Administration (NMPA). Publicly announced on December 16, 2019, this action stemmed from a significant quality deficiency: the tensile strength at the connection points of certain mask batches failed to meet established testing standards. The primary issue identified was the substandard tensile strength of the disposable masks. The affected product, specifically batch number 18110601, involved a total of 40,000 units distributed across China. In response, the company's sales department promptly issued a product recall letter in accordance with regulatory requirements. Xinxiang Changda Medical Device Co., Ltd.'s internal report, dated October 14, 2019, indicated that the entire recalled batch of masks had been utilized, and critically, no adverse reactions or events were observed clinically. This recall underscores the manufacturer's commitment to product safety and compliance with NMPA's medical device regulations.

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