# China NMPA Product Recall - Tracheostomy tube

Source: https://www.globalkeysolutions.net/records/china_product_recall/tyco-healthcare-group-lp-nellcor-puritan-bennett-division/5d6930f3-274a-4b44-a700-bc5c0e9a2f9e/
Source feed: China

> China NMPA product recall for Tracheostomy tube by Tyco Healthcare Group LP Nellcor Puritan Bennett Division published June 18, 2010. Recall level: . Tyco Healthcare Group LP, represented by its Beijing office, issued a voluntary recall for specific 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Recall Report Form for Tracheostomy Tube (Imported Medical Device Registration No. 20072661141)
- Company Name: Tyco Healthcare Group LP Nellcor Puritan Bennett Division
- 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 have caused serious adverse health effects, in which case a leak in the balloon inflation device resulted in no air in the airbag. If the airbag cannot retain air, ventilation may be adversely affected and the tracheostomy tube may need to be replaced immediately.
- Discovering Company: Tyco Healthcare Group LP Nellear Puritan Bennett Division
- Manufacturing Company: Tyco Healthcare Group LP Nellcor Puritan Bennett Division
- Summary: Tyco Healthcare Group LP, represented by its Beijing office, issued a voluntary recall for specific Shiley
Tracheostomy Tube models, as detailed in a National Medical Products Administration (NMPA) report dated June 18, 2010. The recall, impacting products with NMPA Import Registration No. 20072661141, addresses a critical defect in the balloon inflation device. This flaw causes the tube's cuff to leak or deflate, significantly impairing patient ventilation and necessitating immediate tube replacement. Such malfunction poses serious health risks, including a sudden drop in blood oxygen or an increase in blood carbon dioxide levels, especially for patients requiring mechanical ventilation.

The affected products were manufactured between November 1, 2008, and September 25, 2009. Following customer reports, the company initiated a quality alert procedure in July 2009, implementing enhanced inspections. By August 2009, leak testing equipment was installed to rigorously check all manufactured products, and the supplier of the faulty inflation devices was replaced with a previously approved vendor. All known affected batches have been isolated, and unaffected replacement products are readily available to ensure patient safety.

Company: https://www.globalkeysolutions.net/companies/tyco-healthcare-group-lp-nellcor-puritan-bennett-division/92dac02b-bbf5-4091-89b0-ebef19b8e99c/