# China NMPA Product Recall - Ventilator

Source: https://www.globalkeysolutions.net/records/china_product_recall/allergan-shanghai-medical-devices-trading-co-ltd/6ffd697e-680e-47c6-a946-26ceaa44484b/
Source feed: China

> China NMPA product recall for Ventilator by Allergan (Shanghai) Medical Devices Trading Co., Ltd. published October 12, 2020. Recall level: Level 2 Recall. On October 12, 2020, Viman (Shanghai) Medical Device Trading Co., Ltd. announced a voluntary Class I

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Viman (Shanghai) Medical Devices Trading Co., Ltd. is voluntarily recalling Ventilator ventilators.
- Company Name: Allergan (Shanghai) Medical Devices Trading Co., Ltd.
- Publication Date: 2020-10-12
- Product Name: Ventilator
- Recall Level: Level 2 Recall
- Recall Reason: The pneumatic components provided by the supplier may not fully meet the requirements, and there is a very small chance that this may cause abnormal equipment startup (displaying a device malfunction message on the screen) or the equipment to stop supplying air (along with an alarm). This means that if the above abnormalities occur, the equipment will not be usable.
- Discovering Company: Viman (Shanghai) Medical Device Trading Co., Ltd.
- Manufacturing Company: Allergan (Shanghai) Medical Devices Trading Co., Ltd.
- Summary: On October 12, 2020, Viman (Shanghai) Medical Device Trading Co., Ltd. announced a voluntary Class II recall for its Ventilator product. This decision stemmed from internal quality checks that identified a critical issue with pneumatic components supplied by a vendor. During a specific period, these components failed to meet the required specifications, posing a small but significant risk. The identified deficiency could lead to abnormal equipment startup, where the screen displays an error, or the ventilator abruptly ceases air supply while issuing an alarm. In either case, the device would become inoperable, potentially compromising patient care. This proactive recall, overseen by the National Medical Products Administration (NMPA) and reported through the Shanghai Municipal Drug Administration, mandates Viman (Shanghai) Medical Device Trading Co., Ltd. to retrieve all affected units. The company's required action is to conduct this recall to prevent potential patient harm and ensure device reliability. Specific details regarding impacted models, specifications, and batch numbers are available in the official Medical Device Recall Event Report Form.

Company: https://www.globalkeysolutions.net/companies/allergan-shanghai-medical-devices-trading-co-ltd/44f9ba9f-1a9b-46ba-8d34-bd77b4348e8d/