# China NMPA Product Recall - Ventilator

Source: https://www.globalkeysolutions.net/records/china_product_recall/covidien-medical-devices-international-trading-shanghai-co-ltd/ebe1eedb-ae39-4371-94b4-1d6334484d17/
Source feed: China

> China NMPA product recall for Ventilator by Covidien Medical Devices International Trading (Shanghai) Co., Ltd. published June 19, 2017. Recall level: Level 1 Recall. The National Medical Products Administration (NMPA) announced on June 19, 2017, that Covidien Medica

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Covidien Medical Devices International Trading (Shanghai) Co., Ltd. voluntarily recalls ventilators
- Company Name: Covidien Medical Devices International Trading (Shanghai) Co., Ltd.
- Publication Date: 2017-06-19
- Product Name: Ventilator
- Recall Level: Level 1 Recall
- Recall Reason: The product in question spontaneously resets without any warning, affecting normal use by patients.
- Discovering Company: Covidien Medical Devices International Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Covidien Medical Devices International Trading (Shanghai) Co., Ltd.
- Summary: The National Medical Products Administration (NMPA) announced on June 19, 2017, that Covidien Medical Devices International Trading (Shanghai) Co., Ltd. initiated a voluntary Class 1 recall for certain ventilator products. The critical issue identified was that the affected ventilators were spontaneously resetting without triggering any alarms, thereby disrupting normal patient use and potentially compromising patient safety. The company proactively reported this malfunction. This recall falls under the regulatory oversight of the NMPA, which is responsible for ensuring the safety and efficacy of medical devices in China. As a Level 1 recall, it signifies a situation where there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. Covidien Medical Devices International Trading (Shanghai) Co., Ltd. is required to provide detailed information on the specific models, specifications, and batch numbers of the affected products in a 'Medical Device Recall Event Report Form' to facilitate the comprehensive removal of these devices from circulation.

Company: https://www.globalkeysolutions.net/companies/covidien-medical-devices-international-trading-shanghai-co-ltd/4fdf08b9-af8e-4aed-8993-3e905e973d3b/