# China NMPA Product Recall - Disposable sterile endotracheal tube

Source: https://www.globalkeysolutions.net/records/china_product_recall/teleflex-medical/658cee97-29fb-40b4-be5d-756db77d178e/
Source feed: China

> China NMPA product recall for Disposable sterile endotracheal tube by Teleflex Medical published September 10, 2015. Recall level: . Teleflex Medical Sdn.Bhd, the manufacturer, through its distributor Teleflex Medical Devices Trading

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Teleflex Medical Sdn. Bhd recalls single-use sterile endotracheal tubes.
- Company Name: Teleflex Medical
- Publication Date: 2015-09-10
- Product Name: Disposable sterile endotracheal tube
- Recall Reason: The plastic coating of the guidewire in a disposable sterile endotracheal tube is cracked and/or the guidewire is broken.
- Discovering Company: Telif Medical Devices Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Teleflex Medical
- Summary: Teleflex Medical Sdn.Bhd, the manufacturer, through its distributor Teleflex Medical Devices Trading (Shanghai) Co., Ltd., has initiated a voluntary global recall of its single-use sterile endotracheal tubes. This action, reported to the National Medical Products Administration (NMPA) on August 28, 2015, addresses a critical quality issue: the cracking of the plastic coating on the guidewire, or the guidewire itself breaking. These tubes, identified under CFDA (Imported) Registration Certificate No. 20142664102, are vital medical devices used in surgical and emergency situations to establish patient breathing channels. The defect could compromise patient safety during intubation procedures. The recall applies globally, with the manufacturer confirming that while 560 sets were sold to Hong Kong, no affected products were distributed within mainland China. In response, the NMPA has instructed all provincial, autonomous region, and municipal food and drug administration departments to enhance their oversight and management of similar medical products, reinforcing the importance of stringent quality control for life-supporting devices.

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