The following document is a copy of a Press Release from Nellcor/Tyco Healthcare related to the Class I Medical Device Recall of the Shiley Tracheosoft Tracheostomy Tube and Disposable Inner Cannula.
FOR IMMEDIATE RELEASE
Contact: Shay Studley Toland
1-800-346-7197; Ext. 8190
Nellcor/Tyco Healthcare Issues Nationwide Recall of
Tracheosoft XLT Extended Length Tracheostomy Tube
Pleasanton, CA – August 6, 2004 – On July 8, 2004, Nellcor/Tyco Healthcare, initiated a voluntary recall of the Shiley® TracheoSoft® XLT Extended Length Tracheostomy Tube. The Company has shipped 73,355 units over the last four years throughout the U.S. and Canada. This product can be used in the hospital or home-care environment to provide tracheal access for airway management. The recall was prompted by reports of the outer cannula separating from the swivel neck plate. While the number of customer reports of cannula separation is very low, if this failure mode does occur, the outer cannula could travel into the patient’s airway, potentially interfering with breathing or ventilation; which could result in serious injury or death.
Accordingly, in the interest of patient safety, our recall extends to all lots of the following products:
|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|
The Company has received two reports in which the cannula separation was allegedly associated with two patient deaths. 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. As of this date, 80 percent 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.
This action does not affect any other model of Shiley tracheostomy products. We apologize for any disruption this action may cause physicians and their patients. Please be assured that Nellcor/Tyco Healthcare has taken appropriate steps to prevent recurrence of this problem and ensure patient safety.
Clinicians and patients with inquiries should contact our Technical Services Department at 1-800-635-5267, option 3.
About Tyco Healthcare
Tyco Healthcare, a business segment of Tyco International Ltd., is a leading manufacturer, distributor and servicer of medical devices worldwide. Its broad portfolio includes disposable medical supplies, monitoring equipment, medical instruments and bulk analgesic pharmaceuticals, sold under such names as Auto Suture, Kendall, Mallinckrodt, Nellcor, Puritan Bennett, United States Surgical, Valleylab and others.