# China NMPA Product Recall - Medical protective masks

Source: https://www.globalkeysolutions.net/records/china_product_recall/xiamen-minsheng-medical-technology-co-ltd/66a83a10-20d5-4af9-8186-04250a9e1033/
Source feed: China

> China NMPA product recall for Medical protective masks by Xiamen Minsheng Medical Technology Co., Ltd. published June 28, 2019. Recall level: Level 3 Recall. Xiamen Lixia Medical Technology Co., Ltd. initiated a voluntary Class III recall of its medical prot

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Xiamen Lisha Medical Technology Co., Ltd. voluntarily recalls medical protective masks
- Company Name: Xiamen Minsheng Medical Technology Co., Ltd.
- Publication Date: 2019-06-28
- Product Name: Medical protective masks
- Recall Level: Level 3 Recall
- Recall Reason: The packaging labeling of the medical protective masks produced by the company does not comply with the applicable scope of the labeling in the registration certificate, which is inconsistent with the "Regulations on the Management of Instructions and Labels for Medical Devices" (Order No. 6 of the State Food and Drug Administration).
- Discovering Company: Xiamen Lisha Medical Technology Co., Ltd.
- Manufacturing Company: Xiamen Minsheng Medical Technology Co., Ltd.
- Summary: Xiamen Lixia Medical Technology Co., Ltd. initiated a voluntary Class III recall of its medical protective masks on June 28, 2019. The recall stems from a significant discrepancy identified in the product's labeling. Specifically, the applicable scope detailed on the packaging labels did not align with the scope registered on the official certificate for the medical devices. This inconsistency was found to violate the "Regulations on the Management of Instructions and Labels for Medical Devices," promulgated under Order No. 6 of the State Food and Drug Administration. The company's medical protective masks, registered under certificate Fujian Food and Drug Administration Medical Device (Approval) No. 20132640156 (Revised), are subject to this recall. While specific inspection dates are not provided, the recall announcement was made by the Fujian Provincial Drug Administration, indicating regulatory oversight. The required action involves Xiamen Lixia Medical Technology Co., Ltd. actively recalling the affected products. The recall event report form details the specific models, specifications, and batches of the masks involved, ensuring comprehensive removal from distribution. This action underscores the commitment to label accuracy and regulatory compliance in medical device manufacturing.

Company: https://www.globalkeysolutions.net/companies/xiamen-minsheng-medical-technology-co-ltd/3f1c0fae-cad2-4b57-a351-5b86e06308f6/