Health firm recalls 330,000 potentially fatal surgical tubes
A DUBLIN-based company has been forced to recall thousands of surgical ventilation devices after it was found that they contained a major defect which could cause death.
Covidien, which has its executive office in Hatch Street, Dublin, confirmed yesterday that up 330,000 cuffed tracheostomy tubes were being recalled.
The device is used to create an airway and provide a pathway to remove fluid from the trachea and lungs during surgery.
The American Food and Drug Administration classified the recall as Class I, meaning that the affected products could cause serious, even fatal, health problems.
A spokesperson for the HSE said that the Irish Medicines Board (IMB) was responsible for recalls here but it could not be contacted for comment last night.
Covidien came under criticism in Ireland last year when it announced it was transferring jobs to Thailand.
The tubes subject to the current recall were all manufactured in Mexico.
Covidien spokeswoman Rhonda Luniak the recall was global and that some of the tubes were shipped to Ireland.
However, she said that the number of the devices that it made here was likely to be less than 1,000.
The recall has affected tubes manufactured between October 2009 and June 2012.
While Covidien estimates that about 330,000 tubes were manufactured during this time, it was understood that only around 34,000 remain in use.
"All of those tubes are subject to the recall, but at this point, many of them would have already been used and discarded," Ms Luniak said.