Shiley TracheoSoft
Shiley Tracheosoft XLT Extended Length Tracheostomy Tube and Disposable Inner Cannula is an extended length cannula (tube) with accessory components used to provide an artificial airway to assist in the treatment of a variety of respiratory diseases and airway management in adults. The tube is inserted into a tracheostomy incision in a patient's neck and trachea. The Shiley TracheoSoft tracheostomy tube is secured in place through the tube's hub and flange assembly with the use of a holder or neck strap.
The outer cannula may separate from the hub and neck flange allowing the outer cannula to travel farther into the patient's airway and significantly interfere with breathing and ventilation. Failure of the tracheostomy tube can allow the tube to migrate, leading to obstruction of the airway and subsequent lack of ventilation. Airway obstruction or failure to ventilate can lead to permanent neurological injury or death.
Class I recalls are the most serious type of recall and involve situations where there is a reasonable probability that use of the product will cause serious injury or death. The Shiley TracheoSoft Class I recall was initiated in 2004 and affected 73,355 disposable Shiley TracheoSoft units that the firm had shipped to U.S. and international customers over the previous four years.
The following models are affected by the FDA recall:
| Model Number | Description |
|---|---|
| 72110-050 | Size 5, Proximal Extension, Uncuffed |
| 72110-060 | Size 6, Proximal Extension, Uncuffed |
| 72110-070 | Size 7, Proximal Extension, Uncuffed |
| 72110-080 | Size 8, Proximal Extension, Uncuffed |
| 72120-050 | Size 5, Proximal Extension, Cuffed |
| 72120-060 | Size 6, Proximal Extension, Cuffed |
| 72120-070 | Size 7, Proximal Extension, Cuffed |
| 72120-080 | Size 8, Proximal Extension, Cuffed |
| 73110-050 | Size 5, Distal Extension, Uncuffed |
| 73110-060 | Size 6, Distal Extension, Uncuffed |
| 73110-070 | Size 7, Distal Extension, Uncuffed |
| 73110-080 | Size 8, Distal Extension, Uncuffed |
| 73120-050 | Size 5, Distal Extension, Cuffed |
| 73120-060 | Size 6, Distal Extension, Cuffed |
| 73120-070 | Size 7, Distal Extension, Cuffed |
| 73120-080 | Size 8, Distal Extension, Cuffed |
| 77100-050 | Size 5, XLT, Disposable Inner Cannula |
| 77100-060 | Size 6, XLT, Disposable Inner Cannula |
| 77100-070 | Size 7, XLT, Disposable Inner Cannula |
| 77100-080 | Size 8, XLT, Disposable Inner Cannula |
At the time of the recall, the company had received reports of at least instances in which the cannula separation was allegedly associated with a patient death. Those TracheoSoft XLT Tracheostomy Tubes currently in use should be exchanged, when practical, with an alternative model at the discretion and judgment of the patient's physician.
Institutions with affected product have received packages outlining the recall process. It is estimated that a large majority of those customers have responded to the recall action. The U.S. Food and Drug Administration (FDA) and officials in other affected countries have been apprised of this recall action as well.
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