Cook has initiated a voluntary recall of certain lots of its Ciaglia Blue Rhino and Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer Sets and Trays that contain a Covidien 6PERC or 8PERC Shiley™ Tracheostomy Tube, the U.S. Food and Drug Administration (FDA) just announced.
Covidien initiated the voluntary recall of certain lots of its cuffed Shiley™ Tracheostomy tubes due to the product’s cuff not holding air as a result of leaks in the pilot balloon inflation assembly. If a cuff does not hold air, ventilation will be adversely affected since the ability to generate positive pressure in the airway could be compromised by lack of cuff seal. This defect could result in a sudden decrease in the amount of oxygen in the blood or a sudden increase in the amount of carbon dioxide in the blood, especially if the patient requires assisted mechanical ventilation. In some instances, this could result in serious injury, including death.
The voluntary recall only affects lot numbers from a specific period of time. Cook mailed a detailed Customer Notification letter to each customer who received an affected lot number of these devices. Customers should review product in inventory and current use to identify product from the affected lot codes. Detailed steps are provided in the Customer URGENT: PRODUCT RECALL Customer Notification letter for return and disposition of affected product(s), which were mailed April 21, 2010. A complete breakdown of affected product can be accessed on the FDA website here.
Adequate supplies of unaffected replacement product are available. To return the affected product for credit, Cook Medical’s Customer Relations Department can be reached by telephone at 1-800-457-4500 or 1-812-339-2235, by Fax to 1-812-339-7316, or by email to CustomerRelationsNA@CookMedical.com.
Healthcare professionals and customers may report adverse events or quality problems experienced with the use of this product to the FDA’s MedWatch Adverse Event Reporting program either online at www.fda.gov/medwatch/report.htm; by regular mail using the postage-paid FDA form 3500 available at http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm, which can be mailed to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787; by Fax to 1-800-FDA-0178; or by telephone at 1-800-332-1088.
The Associated Press reported in April that the earlier Covidien recall was implemented following reports of three deaths and about 1,200 reports of leaks associated with the recalled breathing devices. Tom Gasparoli, an FDA spokesman, told the AP that the FDA was investigating the deaths and reports of leaks saying that the agency was “investigating the circumstances surrounding the deaths of three patients that may be associated with leaks in the tracheostomy tubes made by Covidien,” quoted the AP.
Sherri Hughes-Smith, spokeswoman for Covidien, said the firm received information that a Shiley TM cuffed tracheostomy tube was in use with the three patients who died, said the AP. “However, we have been unable to obtain detailed information about these incidents, so we cannot determine what role, if any, the product issue that led to this recall may have played,” she explained, quoted the AP. In that case, the recall was also initiated due to the product’s cuff not holding air as a result of leaks in the pilot balloon inflation assembly.
