Cook brand Ciaglia Blue Rhino/Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer Sets and Trays

Sets and Trays contain Covidien 6PERC or 8PERC Shiley Tracheostomy Tube

Audience: Hospital Risk Manager, Anesthesiology

Issue: FDA notified healthcare professionals that Cook initiated a voluntary recall of certain lots of Ciaglia Blue Rhino/Blue Dolphin Percutaneous Tracheostomy Introducer Sets/Trays that contain Covidien 6PERC or 8PERC Shiley Tracheostomy Tube due to the product’s cuff not holding air. The voluntary recall only affects lot numbers noted in the press release at link below. 

Background: The defect is 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 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 and could result in serious injury, including death.

Recommendation: Cook has mailed a detailed Customer Notification letter to each customer who has 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. Healthcare professionals 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 by regular mail or fax.

• Online: www.fda.gov/medwatch/report.htm
• Regular Mail: Use postage-paid FDA form 3500 available at: http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm
• Mail to address on pre-addressed form or fax to 1-800-FDA-0178

Read the complete MedWatch 2010 Safety summary, including a link to the firm press release, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm220022.htm