# China NMPA Product Recall - Tracheostomy tube

Source: https://www.globalkeysolutions.net/records/china_product_recall/singapore-tyco-medical-devices-co-ltd-beijing-office/fd8d1190-63c1-413b-9fe3-d67a3fb02bf1/
Source feed: China

> China NMPA product recall for Tracheostomy tube by Singapore Tyco Medical Devices Co., Ltd. Beijing Office published June 18, 2010. Recall level: . Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, through its Singapore Tyco Medical Devic

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Recall Report Form for Tracheostomy Tube (Imported Medical Device Registration No. 20072661153)
- Company Name: Singapore Tyco Medical Devices Co., Ltd. Beijing Office
- Publication Date: 2010-06-18
- Product Name: Tracheostomy tube
- Recall Reason: We have received customer reports regarding certain Shiley™ tracheostomy tubes with airbags that may cause serious adverse health effects. In these cases, a leak in the balloon inflation device results in no air in the airbag. If the airbag cannot retain air, ventilation may be adversely affected, and the tracheostomy tube may need immediate replacement. This voluntary recall only applies to batches within a specific period. Regarding the affected products, if the airbag cannot retain air, positive pressure can be generated in the airway, adversely affecting ventilation. This can cause a sudden drop in blood oxygen levels or a sudden increase in blood carbon dioxide levels, especially if the patient requires assisted mechanical ventilation. A quality alert program was initiated in July 2009, ensuring that all batches of products manufactured, including custom tracheostomy tubes, are inspected 6/12/18 and 24 hours a day. In August 2009, leak testers were installed to test all manufactured products to detect malfunctions. The factory-initiated process also includes removing all affected balloon inflation devices from the products. The supplier of the inflation device has been changed to a previously approved vendor whose product quality history has been verified.
- Discovering Company: Singapore Tyco Medical Devices Co., Ltd. Beijing Representative Office
- Manufacturing Company: Singapore Tyco Medical Devices Co., Ltd. Beijing Office
- Summary: Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, through its Singapore Tyco Medical Devices Co., Ltd. Beijing Representative Office, issued a voluntary recall report to the National Medical Products Administration (NMPA) on June 18, 2010. The report concerned Shiley


Tracheostomy Tubes (NMPA Imported Medical Device Registration No. 20072661153), a product vital for pediatric patients requiring assisted ventilation across a wide global distribution, including China.
The primary issue identified was a defect in the balloon inflation device, causing the tracheostomy tube's airbag to leak and fail to retain air. This malfunction posed a significant health risk, potentially leading to compromised ventilation, sudden drops in blood oxygen, or increases in carbon dioxide, particularly critical for patients on mechanical ventilation. The affected products were manufactured between November 1, 2008, and September 25, 2009.
In response, the company initiated a comprehensive corrective action plan. This began in July 2009 with enhanced quality alert procedures and continuous batch inspections. By August 2009, leak testers were installed to detect malfunctions, and all affected airbag inflators were removed. The supplier for the faulty inflators was replaced with an approved vendor. Tyco Healthcare also isolated all affected batches and ensured a sufficient supply of compliant replacement products. The recall activity in China involved a total of 1096 units across distributor and hospital inventories.

Company: https://www.globalkeysolutions.net/companies/singapore-tyco-medical-devices-co-ltd-beijing-office/b4276b6e-f6f5-4d0b-96de-f806a426dc56/