# China NMPA Product Recall - Ventilator

Source: https://www.globalkeysolutions.net/records/china_product_recall/koo-medical-equipment-shanghai-co-ltd/3e8ebe9d-da2b-4c0d-8f87-74dbc8dfadf0/
Source feed: China

> China NMPA product recall for Ventilator by Koo Medical Equipment (Shanghai) Co., Ltd. published January 25, 2018. Recall level: Level 3 Recall. Dräger Medical Devices (Shanghai) Co., Ltd. initiated a voluntary Level III recall of its ventilator

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Dräger Medical Equipment (Shanghai) Co., Ltd. voluntarily recalls ventilators
- Company Name: Koo Medical Equipment (Shanghai) Co., Ltd.
- Publication Date: 2018-01-25
- Product Name: Ventilator
- Recall Level: Level 3 Recall
- Recall Reason: Some ventilators on the market have switch markings that are inconsistent with the markings in their instruction manuals.
- Discovering Company: Dräger Medical Equipment (Shanghai) Co., Ltd.
- Manufacturing Company: Koo Medical Equipment (Shanghai) Co., Ltd.
- Summary: Dräger Medical Devices (Shanghai) Co., Ltd. initiated a voluntary Level III recall of its ventilators, as reported by the National Medical Products Administration (NMPA) on January 25, 2018. This action was prompted by the discovery that switch markings on certain ventilators were inconsistent with the information provided in their instruction manuals. The affected products, identified under Registration Certificate No.: 20173546064, encompass specific models, specifications, and batches, detailed in the "Recall Event Report Form." This recall falls under the regulatory oversight of the Shanghai Food and Drug Administration Medical Device Recall 2018-003, underscoring the company's commitment to adhering to medical device regulations and ensuring product accuracy. The voluntary recall demonstrates Dräger Medical Devices' proactive approach to addressing potential discrepancies that could lead to user confusion or operational issues, thereby upholding product safety and regulatory compliance.

Company: https://www.globalkeysolutions.net/companies/koo-medical-equipment-shanghai-co-ltd/629448d1-2f5c-4db0-8ac4-522b6d76800f/