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

Source: https://www.globalkeysolutions.net/records/china_product_recall/teleflex-medical/1b8f7acf-61a5-454f-a9d4-f161f3599bff/
Source feed: China

> China NMPA product recall for Disposable sterile endotracheal tube Tracheal Tube by Teleflex Medical published July 04, 2023. Recall level: Level 1 Recall. Teleflex Medical Sdn. Bhd., in conjunction with Teleflex Medical Devices Trading (Shanghai) Co., Ltd

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Teleflex Medical Sdn. Bhd. is recalling and modifying its single-use sterile endotracheal tubes.
- Company Name: Teleflex Medical
- Publication Date: 2023-07-04
- Product Name: Disposable sterile endotracheal tube Tracheal Tube
- Recall Level: Level 1 Recall
- Recall Reason: The 15mm connector of the affected product disconnected from the endotracheal tube (ET tube), potentially leading to a decrease in oxygen saturation.
- Discovering Company: Telif Medical Devices Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Teleflex Medical
- Summary: Teleflex Medical Sdn. Bhd., in conjunction with Teleflex Medical Devices Trading (Shanghai) Co., Ltd., has initiated a voluntary recall and modification of its single-use sterile endotracheal tubes, specifically the Tracheal Tube (National Medical Device Registration Certificate No. 20192081715, National Food and Drug Administration Medical Device (Imported) No. 20142664102). The recall, initially classified as Level II on May 2, 2023, has been escalated to a Level I recall by the National Medical Products Administration (NMPA), as reported on July 4, 2023. This critical action stems from a significant safety concern: the 15mm connector of the affected product has the potential to disconnect from the endotracheal tube. Such a disconnection could lead to a decrease in oxygen saturation for patients, posing a serious health risk. The company is taking measures to address this critical issue to ensure patient safety and compliance with regulatory standards set by the NMPA. Further details on specific models, specifications, and batches are provided in the "Medical Device Recall Event Report Form" attachment.

Company: https://www.globalkeysolutions.net/companies/teleflex-medical/5312ec09-d2e9-475a-a823-43bf4934f597/