# China NMPA Product Recall - Disposable sterile endotracheal tube

Source: https://www.globalkeysolutions.net/records/china_product_recall/teleflex-medical/322220b3-d982-471e-badc-41fb3d4ece9a/
Source feed: China

> China NMPA product recall for Disposable sterile endotracheal tube by Teleflex Medical published March 10, 2015. Recall level: Level III. Teleflex Medical Devices Trading (Shanghai) Co., Ltd. initiated a voluntary Level III recall of its 

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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 endotracheal tubes.
- Company Name: Teleflex Medical
- Publication Date: 2015-03-10
- Product Name: Disposable sterile endotracheal tube
- Recall Level: Level III
- Recall Reason: This recall is due to a very slight discrepancy between the cuff diameter indicated on the endotracheal tube label and the actual cuff diameter, even though the actual product's cuff diameter meets the required specifications. Using the incorrectly labeled product will not pose any additional clinical risk, and no customer complaints regarding this issue have been received to date.
- Discovering Company: Telif Medical Devices Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Teleflex Medical
- Summary: Teleflex Medical Devices Trading (Shanghai) Co., Ltd. initiated a voluntary Level III recall of its single-use sterile endotracheal tubes, as reported to the National Medical Products Administration (NMPA) on January 30, 2015, and publicly announced on March 10, 2015. The recall stems from a minor labeling discrepancy where the indicated cuff diameter on the product label differed slightly from the actual cuff diameter. Despite this, the actual product specifications meet all required standards, and the company confirmed no additional clinical risks are posed by the mislabeling. Furthermore, no customer complaints related to this issue have been received. The recall affects 75,815 sets of endotracheal tubes sold within China, out of a total global production of 78,508 units. As a corrective action, Teleflex is notifying all authorized distributors to facilitate the return of the affected products. All remaining stock of 2,418 units has been quarantined, and the company awaits further instructions from the manufacturer regarding the recalled items. This action aligns with NMPA's medical device regulatory oversight, ensuring product information accuracy.

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