# China NMPA Product Recall - Medical surgical masks

Source: https://www.globalkeysolutions.net/records/china_product_recall/suzhou-xinlun-cleanroom-technology-co-ltd/deec2fb4-39be-483d-8212-434d769ede9f/
Source feed: China

> China NMPA product recall for Medical surgical masks by Suzhou Xinlun Cleanroom Technology Co., Ltd. published December 19, 2018. Recall level: Level 3 Recall. The National Medical Products Administration (NMPA) announced that Suzhou Xinlun Cleanroom Technolog

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Suzhou Xinlun Clean Technology Co., Ltd. voluntarily recalls medical surgical masks
- Company Name: Suzhou Xinlun Cleanroom Technology Co., Ltd.
- Publication Date: 2018-12-19
- Product Name: Medical surgical masks
- Recall Level: Level 3 Recall
- Recall Reason: The ear loop tension failed to meet the standard requirements during random inspection.
- Discovering Company: Suzhou Xinlun Cleanroom Technology Co., Ltd.
- Manufacturing Company: Suzhou Xinlun Cleanroom Technology Co., Ltd.
- Summary: The National Medical Products Administration (NMPA) announced that Suzhou Xinlun Cleanroom Technology Co., Ltd. initiated a Level III voluntary recall of its medical surgical masks. This action stemmed from a 2018 national medical device spot check which revealed that the product's ear loop tension failed to meet required standards. Specifically, the company identified unstable ear loop spot welding as the root cause, linked to a temporary gas pipeline leak that resulted in a workshop shutdown. The affected products, identified by Registration Certificate Code: Su Xie Zhu Zhun 20162641124, are designed for use by medical personnel and were distributed within China. In response to the inspection failure, Suzhou Xinlun Cleanroom Technology Co., Ltd. has taken several corrective actions. These include downgrading all products manufactured during the identified abnormal period. Furthermore, the company doubled the quantity and frequency of small-volume production to enhance quality control and retrieve all relevant production and quality inspection records. The recall emphasizes the company's commitment to addressing quality issues identified through regulatory oversight.

Company: https://www.globalkeysolutions.net/companies/suzhou-xinlun-cleanroom-technology-co-ltd/5eebf9e1-f2ba-477b-aab3-4417b95303c6/