Covidien Plc, a medical device company based in Dublin, recalled up to 330,000 surgical ventilation devices on 18th July 2012. The devices, called the cuffed Shiley 8LPC, 8FEN tracheostomy tubes, were used during surgery to create an airway and pathway to remove fluid from the windpipe (trachea) and lungs. The defective tubes were manufactured between 1st October 2009 and 26th June 2012 and were recalled after it emerged that a major defect with the devices could lead to serious health problems and even death. It is believed that up to 1,000 devices were manufactured in Ireland with the majority manufactured in Mexico, however the tubes were also imported into Ireland. Covidien has claimed that only 34,000 of the 330,000 tubes remain in use.
On announcing the recall Covidien Plc said; “Customers are instructed to return all Shiley 8LPC and 8FEN tracheostomy tubes from the affected lots. If one of the recalled tubes is already in use in a patient, the Company recommends that the tube be replaced as soon as clinically appropriate as determined by the patient’s physician. If the physician advises leaving the tracheostomy tube in place, the Company strongly encourages that the frequency of direct patient observation be increased.” However, on 23rd July 2012 in it’s Urgent Field Safety Notice Covidien stated; “We expect to have the Shiley 8LPC, 8FEN, replacement product available in our region within approximately two months.”, but they did not determine specifically what, if any, alternative product was available in the meantime should the Shiley tubes need to be removed immediately.
Since the recall the Irish Medicines Board has yet to provide guidelines or recommendations to those affected by the recall while the US Food and Drug Administration issued a safety alert stating; “Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.”
