# China NMPA Product Recall - Disposable sterile endotracheal tube Tracheal Tube

Source: https://www.globalkeysolutions.net/records/china_product_recall/telif-medical-devices-trading-shanghai-co-ltd/3594825f-e85d-4413-b385-4317e644d4d0/
Source feed: China

> China NMPA product recall for Disposable sterile endotracheal tube Tracheal Tube by Telif Medical Devices Trading (Shanghai) Co., Ltd. published July 22, 2021. Recall level: Level 2 Recall. Talifo Medical Devices Trading (Shanghai) Co., Ltd. initiated a voluntary Class II recall of its Sin

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Talifu Medical Devices Trading (Shanghai) Co., Ltd. is voluntarily recalling its single-use sterile endotracheal tubes (Tracheal Tube).
- Company Name: Telif Medical Devices Trading (Shanghai) Co., Ltd.
- Publication Date: 2021-07-22
- Product Name: Disposable sterile endotracheal tube Tracheal Tube
- Recall Level: Level 2 Recall
- Recall Reason: Reports indicate that the endotracheal intubation cuff may inflate while the indicating balloon is still deflated. When the indicating balloon is deflated, there is a risk of patient injury because the balloon no longer reflects the cuff's position.
- Discovering Company: Telif Medical Devices Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Telif Medical Devices Trading (Shanghai) Co., Ltd.
- Summary: Talifo Medical Devices Trading (Shanghai) Co., Ltd. initiated a voluntary Class II recall of its Single-Use Sterile Endotracheal Tubes (Tracheal Tube, Registration Certificate No.: 20192081715) on July 22, 2021. The recall, published by the National Medical Products Administration (NMPA), addresses a critical product defect. The primary issue identified is that the endotracheal tube cuff may inflate even while its indicator balloon remains deflated. This malfunction means the indicator balloon fails to accurately reflect the cuff's actual condition, presenting a significant risk of patient injury. Clinicians are advised to carefully evaluate the risks and benefits associated with extubation and reintubation for individual patients, given the ongoing safety concerns. Under the oversight of the NMPA, Talifo Medical Devices Trading (Shanghai) Co., Ltd. is taking proactive steps to remove the affected products from the market. The specific models, specifications, and batch numbers subject to this recall are detailed in an accompanying Medical Device Recall Event Report Form. This voluntary action underscores the company's commitment to patient safety and compliance with regulatory standards.

Company: https://www.globalkeysolutions.net/companies/telif-medical-devices-trading-shanghai-co-ltd/c0fdb740-6e25-4782-94b0-a6f732669ee5/