Covidien has confirmed that it notified customers on July 18, 2012, about a voluntary global recall of certain lots of its Shiley™ reusable cannula, cuffed adult tracheostomy tubes, size 8. This action was in response to reports of volume leakage and/or disconnection between the inner and outer cannulae.
This voluntary recall was initiated following an analysis by Covidien of customer reports of volume leakage and/or disconnection between the inner and outer cannula involving certain specific tracheostomy tubes. These events were typically observed during mechanical ventilation and represent a small fraction of the tubes distributed. Volume leakage and/or disconnection could impact ventilation.
Covidien has alerted customers by mail of its voluntary recall action and provided instructions on returning the devices. The U.S. FDA and other regulatory bodies have also been notified.
Replacements for the affected lots of product are expected to be available soon. Alternative Covidien products to meet customer needs for the impacted product codes are available.
Product code 8FEN, lot numbers from 0910000342 through 1101001558 and 110201893X through 120600700X
Product code 8LPC, lot numbers from 0910000346 through 1101001823 and 110200327X through 120600351X
Customers are instructed to return all Shiley 8LPC and 8FEN tracheostomy tubes from the affected lots. If one of the recalled tubes is already in use in a patient, the Company recommends that the tube be replaced as soon as clinically appropriate as determined by the patient’s physician. If the physician advises leaving the tracheostomy tube in place, the Company strongly encourages that the frequency of direct patient observation be increased.Actions
Only certain lots of the size 8 adult, reusable tracheostomy tubes are included in this product recall. All other sizes and styles of Shiley™ tracheostomy tubes are unaffected by this action. These tracheostomy tubes were distributed from October 2009 through June 2012.
Adverse reactions experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by phone or fax.
Source: FDA, Covidien