# China NMPA Product Recall - Disposable sterile tracheostomy tube

Source: https://www.globalkeysolutions.net/records/china_product_recall/telif-medical-devices-trading-shanghai-co-ltd/0b3930ec-b104-41ef-9ecc-30c764ba2786/
Source feed: China

> China NMPA product recall for Disposable sterile tracheostomy tube by Telif Medical Devices Trading (Shanghai) Co., Ltd. published October 29, 2018. Recall level: Level 2 Recall. Terif Medical Devices Trading (Shanghai) Co., Ltd. initiated a voluntary Level II recall of its disp

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Teriform Medical Devices Trading (Shanghai) Co., Ltd. has initiated a voluntary recall of disposable sterile tracheostomy tubes.
- Company Name: Telif Medical Devices Trading (Shanghai) Co., Ltd.
- Publication Date: 2018-10-29
- Product Name: Disposable sterile tracheostomy tube
- Recall Level: Level 2 Recall
- Recall Reason: The product's inner diameter exceeds the specified dimensional tolerance and does not meet the standard.
- Discovering Company: Telif Medical Devices Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Telif Medical Devices Trading (Shanghai) Co., Ltd.
- Summary: Terif Medical Devices Trading (Shanghai) Co., Ltd. initiated a voluntary Level II recall of its disposable sterile tracheostomy tubes, as publicly reported on October 29, 2018, by the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration. The primary issue identified was that the inner diameter of the affected products exceeded the specified dimensional tolerance, indicating a failure to meet established quality standards. This critical non-conformance impacted devices covered by various registration certificates. In response to this product defect, Terif Medical Devices Trading (Shanghai) Co., Ltd. undertook a voluntary recall to address the potential risks associated with the non-compliant devices. The company provided a "Medical Device Recall Event Report Form" detailing specific product numbers, specifications, and batch identifiers to facilitate the recall process and ensure effective removal of affected products from the market. This action highlights the company's commitment to compliance with medical device regulations and patient safety.

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