# China NMPA Product Recall - Disposable sterile medical masks

Source: https://www.globalkeysolutions.net/records/china_product_recall/changdong-medical-devices-group-co-ltd/f02c2904-e5b5-4b46-b312-ff56923b5623/
Source feed: China

> China NMPA product recall for Disposable sterile medical masks by Changdong Medical Devices Group Co., Ltd. published October 26, 2020. Recall level: Level 3 Recall. Changdong Medical Device Group Co., Ltd. initiated a voluntary Level III recall of its disposable st

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Changdong Medical Devices Group Co., Ltd. has voluntarily recalled disposable sterile medical masks.
- Company Name: Changdong Medical Devices Group Co., Ltd.
- Publication Date: 2020-10-26
- Product Name: Disposable sterile medical masks
- Recall Level: Level 3 Recall
- Recall Reason: Tests conducted by relevant departments revealed that the masks failed to meet bacterial filtration efficiency standards.
- Discovering Company: Changdong Medical Devices Group Co., Ltd.
- Manufacturing Company: Changdong Medical Devices Group Co., Ltd.
- Summary: Changdong Medical Device Group Co., Ltd. initiated a voluntary Level III recall of its disposable sterile medical masks after an inspection revealed substandard bacterial filtration efficiency. This non-compliance violates established bacterial filtration efficiency regulations for medical devices. The recall, reported on October 23, 2020, specifically targets 20,000 units of medium-sized ear-loop masks from batch 200602, distributed within China, including Anhui Province. The issue was discovered through an inspection by a relevant department operating under the framework of China's provincial drug administration. As part of the required actions, Changdong Medical Device Group Co., Ltd. committed to recalling all affected masks within seven days for immediate processing. Corrective measures involve a comprehensive review of the manufacturing process, inspection and testing of raw materials, and implementation of stricter controls to ensure future product compliance. The company will bear all expenses incurred during the return process. This action emphasizes the critical need for medical device manufacturers to maintain rigorous quality and safety standards.

Company: https://www.globalkeysolutions.net/companies/changdong-medical-devices-group-co-ltd/abbce35b-9a91-429c-b788-23c972d165b3/