Covidien just announced a recall of its Shiley Adult Tracheostomy Tubes, the U.S. Food & Drug Administration said. The Shiley Adult Tracheostomy Tube recall has been deemed Class I by the FDA, which means there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Covidien said it notified customers on July 18, 2012 about its global recall of certain lots of its Shiley reusable cannula, cuffed adult tracheostomy tubes, size 8. This action followed reports of volume leakage and/or disconnection between the inner and outer cannulae. Analysis by Covidien of customer reports of volume leakage and/or disconnection between the inner and outer cannula involving these specific tracheostomy tubes revealed that 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 advises that its customers should 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, Covidien recommends 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, Covidien strongly encourages that the frequency of direct patient observation be increased.
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. The recalled tracheostomy tubes were distributed from October 2009 through June 2012 and include the following:
- Product Code 8FEN: Starting Lot Number 0910000342; Ending Lot Number 1101001558
- Product Code 8FEN: Starting Lot Number 110201893X; Ending Lot Number 120600700X
- Product Code 8LPC: Starting Lot Number 0910000346; Ending Lot Number 1101001823
- Product Code 8LPC: Starting Lot Number 110200327X; Ending Lot Number 120600351X
Covidien alerted its customers by mail of its recall action and provided instructions on returning the devices; the FDA and other regulatory bodies have also been notified. Replacements for the affected lots of product are expected to be available soon and alternative Covidien products to meet customer needs for the impacted product codes are available. Covidien Technical Services can be reached, toll-free, at 1.800.635,5267, option 3, then option 1. Support is available during business hours with emergency service support available after these times.
This is not the first time this year that Covidien has had issues with one of its products. Earlier last month we wrote that Covidien catheters were linked to nine deaths and a number of other incidents, prompting the FDA to issue an alert on its web site. The catheters are manufactured by a unit of the device maker and are meant to block the flow of blood to abnormal brain blood vessels.
Earlier this year, we wrote that Covidien announced a recall on all lots of its Duet TRS Universal Straight and Articulating Single Use Loading Units after receiving 13 reports of serious injuries and three reports of death when the units were used following thoracic surgery. Covidien said the device should not be used following thoracic surgery and believes using this device after a thoracic surgery could cause life-threatening complications including serious injuries to the “adjacent anatomical structures” in the throat.