# China NMPA Product Recall - Neurological monitoring and endotracheal intubation

Source: https://www.globalkeysolutions.net/records/china_product_recall/shanghai-amsino-medical-devices-co-ltd/3c7a3986-8c02-477f-8d15-4a6d4cb3b46b/
Source feed: China

> China NMPA product recall for Neurological monitoring and endotracheal intubation by Shanghai Amsino Medical Devices Co., Ltd. published July 30, 2021. Recall level: Level 3 Recall. Shanghai Yingshou Medical Device Co., Ltd. initiated a voluntary Class III recall of its neurologica

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Shanghai Yingshou Medical Devices Co., Ltd. is voluntarily recalling its neurological monitoring endotracheal tubes.
- Company Name: Shanghai Amsino Medical Devices Co., Ltd.
- Publication Date: 2021-07-30
- Product Name: Neurological monitoring and endotracheal intubation
- Recall Level: Level 3 Recall
- Recall Reason: The product in question lacked labeling of storage conditions on its packaging. An internal audit revealed that the packaging of the retained product samples did not indicate the temperature and humidity storage conditions, which was inconsistent with the instruction manual.
- Discovering Company: Shanghai Yingshou Medical Devices Co., Ltd.
- Manufacturing Company: Shanghai Amsino Medical Devices Co., Ltd.
- Summary: Shanghai Yingshou Medical Device Co., Ltd. initiated a voluntary Class III recall of its neurological monitoring tracheal tubes on July 30, 2021. This action stemmed from an internal audit conducted in July 2021, which revealed a critical discrepancy in product labeling. The audit identified that the packaging for retained products failed to specify essential temperature and humidity storage environment conditions, a direct inconsistency with the product's instructions for use. Under the guidance of national regulations overseen by the National Medical Products Administration (NMPA), the company is proactively withdrawing the affected products. The recall, registered under Index No. JGXX-2021-10419, emphasizes the company's commitment to compliance and patient safety. A Class III recall indicates that the use of or exposure to a violative product is not likely to cause adverse health consequences. Detailed information regarding specific models, specifications, and batch numbers is available in the accompanying Medical Device Recall Event Report Form. This recall highlights the importance of accurate and complete product labeling in the medical device industry to ensure safe and effective product handling.

Company: https://www.globalkeysolutions.net/companies/shanghai-amsino-medical-devices-co-ltd/c2b7f98f-5bac-4401-8f3b-e278676070d4/