# China NMPA Product Recall - Medical surgical masks

Source: https://www.globalkeysolutions.net/records/china_product_recall/henan-jianqi-medical-equipment-co-ltd/d6d83fbb-ab27-444c-9a41-f2ce36f67c78/
Source feed: China

> China NMPA product recall for Medical surgical masks by Henan Jianqi Medical Equipment Co., Ltd. published November 01, 2017. Recall level: Level 3 Recall. On November 1, 2017, the National Medical Products Administration (NMPA) published a voluntary recal

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Henan Jianqi Medical Device Co., Ltd. voluntarily recalls medical surgical masks.
- Company Name: Henan Jianqi Medical Equipment Co., Ltd.
- Publication Date: 2017-11-01
- Product Name: Medical surgical masks
- Recall Level: Level 3 Recall
- Recall Reason: The product pressure difference does not meet the standard requirements.
- Discovering Company: Henan Jianqi Medical Equipment Co., Ltd.
- Manufacturing Company: Henan Jianqi Medical Equipment Co., Ltd.
- Summary: On November 1, 2017, the National Medical Products Administration (NMPA) published a voluntary recall announcement concerning Henan Jianqi Medical Device Co., Ltd. The company initiated a Level III recall for a specific batch of its medical surgical masks. The primary reason for this action was the discovery that the product failed to meet established standards regarding pressure difference. This non-compliance indicates a potential issue with the mask's breathability, which is a critical performance parameter for medical devices designed for surgical use. Henan Jianqi Medical Device Co., Ltd. acknowledged the deviation from the required specifications, leading to their proactive decision to remove the affected products from the market. The recall details, including specific product models, specifications, and batch numbers, were documented in an accompanying 'Medical Device Recall Form.' The NMPA, as the authoritative regulatory body, oversees such market actions to safeguard public health and ensure the quality and safety of medical devices distributed within its jurisdiction. This incident underscores the ongoing regulatory vigilance required to maintain high standards in medical product manufacturing and distribution, ensuring that all devices meet their intended performance criteria before reaching end-users.

Company: https://www.globalkeysolutions.net/companies/henan-jianqi-medical-equipment-co-ltd/798abff2-100c-4f83-903d-ce67415525f9/