# China NMPA Product Recall - Tracheostomy tube

Source: https://www.keypedia.com/records/china_product_recall/nellcor-puritan-bennett-inc/0dde9508-10f0-42d0-b577-b5c5cade9e31
Source feed: China

> China NMPA product recall for Tracheostomy tube by Nellcor Puritan Bennett Inc published August 16, 2012. Recall level: Level 1 Recall. Nellcor Puritan Bennett Inc. initiated a Class I global recall of specific batches of its No. 8 trac

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Nellcor Puritan Bennett Inc. of the United States is recalling tracheostomy tubes.
- Company Name: Nellcor Puritan Bennett Inc
- Publication Date: 2012-08-16
- Product Name: Tracheostomy tube
- Recall Level: Level 1 Recall
- Recall Reason: Some size 8 tracheostomy tubes (with reusable inner cannula and cuff) may leak air and/or break between the inner and outer layers of the cannula, which may adversely affect the patient's mechanical ventilation and may require immediate replacement.
- Discovering Company: Tyco Medical Devices International Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Nellcor Puritan Bennett Inc
- Summary: Nellcor Puritan Bennett Inc. initiated a Class I global recall of specific batches of its No. 8 tracheostomy tubes (models 8FEN and 8LPC) due to critical product defects. This recall, reported to China's National Medical Products Administration (NMPA) in August 2012 via Tyco Medical Devices International Trading (Shanghai) Co., Ltd., addresses issues of air leakage and/or disconnection between the inner and outer cannulas of these devices. Such malfunctions primarily occur during mechanical ventilation and pose a significant risk, as they can adversely affect patient breathing and require immediate product replacement. The affected products, identified by specific batch numbers spanning from 2009 to 2012, involve 8028 units produced or imported, with 7425 units sold within China. As a corrective action, Nellcor Puritan Bennett Inc. is proactively recalling all identified faulty products, which are to be returned to the Covidien Singapore warehouse. The NMPA has instructed provincial, autonomous region, and municipal food and drug administrations to enhance their supervision and management of similar medical devices to ensure patient safety.

Company: https://www.keypedia.com/companies/nellcor-puritan-bennett-inc/b86a3983-4e52-4c14-8f5a-0cf43811605b