# China NMPA Product Recall - Medical protective masks

Source: https://www.globalkeysolutions.net/records/china_product_recall/xinxiang-jinhuan-medical-equipment-co-ltd/0d10c3e0-0474-4f53-869f-365cabce5c8c/
Source feed: China

> China NMPA product recall for Medical protective masks by Xinxiang Jinhuan Medical Equipment Co., Ltd. published January 17, 2019. Recall level: Level 3 Recall. Xinxiang Changda Medical Device Co., Ltd. initiated a voluntary Level III recall of specific batches

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Xinxiang Changda Medical Equipment Co., Ltd. has voluntarily recalled its medical protective masks.
- Company Name: Xinxiang Jinhuan Medical Equipment Co., Ltd.
- Publication Date: 2019-01-17
- Product Name: Medical protective masks
- Recall Level: Level 3 Recall
- Recall Reason: Filtration efficiency does not meet standard requirements
- 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 Level III recall of specific batches of its medical protective masks, as reported by the National Medical Products Administration (NMPA) on January 17, 2019. The primary reason for this recall was the critical finding that the filtration efficiency of these masks did not meet the required standard specifications. This deficiency poses a potential risk to users, as the protective capabilities of the masks would be compromised, failing to adequately protect against airborne particles as intended for medical use.

Under the regulatory oversight of the NMPA, the company formally declared this recall after identifying the non-conformance. A Level III recall signifies that the product defect is unlikely to cause adverse health consequences, but still warrants removal from the market to prevent potential issues and ensure product quality. The required action for Xinxiang Changda Medical Device Co., Ltd. involves actively retrieving all affected medical protective masks from distribution channels and users. This measure is crucial for upholding product integrity, complying with medical device regulations, and ensuring consumer safety. The incident highlights the rigorous standards expected in medical device manufacturing and the importance of continuous quality assurance processes.

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