Covidien has just initiated a voluntary recall of certain lots of its cuffed Shiley tracheostomy tubes and Custom/Specialty tracheostomy tubes, the U.S. Food and Drug Administration (FDA) announced.
According to The Associated Press (AP), the 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 is investigating the deaths and reports of leaks. The FDA is “investigating the circumstances surrounding the deaths of three patients that may be associated with leaks in the tracheostomy tubes made by Covidien,” said Gasparoli, 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.
The recall was initiated 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. Only those Shiley TM tracheostomy tubes from the lot numbers listed on the FDA page here are affected by this recall action.
The FDA is advising customers to review product in inventory and current use to identify product from the affected lot codes. Detailed steps are provided in the Customer Notification letter for return and disposition of the affected product, which is dated April 13, 2010, and is posted here. Once there, click on the “Product Notices” tab.
The lot number of the Custom/Specialty tracheostomy tubes is clearly printed on the left side of the Soft Swivel Flange and on the carton and pouch in which the product was shipped. For the products listed in Table 2 on the FDA page: Products with lot codes in which the first four numbers are in the range from 0904 to 0912 may be affected; consult Table 2 for specific lot code ranges for each product code. Products in Table 2 on the FDA page with lot code numbers starting with 0903 or lower, and those with lot code numbers starting with 1001 or higher, are not affected.
To return the affected product for credit, contact the Technical Services group at 1-800-635-5267. Choose option 3, then option 1, and reference the “Return Goods Authorization (RGA) Number.”
Adverse reactions can be reported to the FDA at 800-332-1088. The adverse reactions reporting form can be accessed at: http://www.fda.gov/medwatch/report.htm.
