On August 5, 2016, the FDA has classified Dräger’s recall of its VenStar Oxylog 3000 disposable pediatric patient breathing circuit as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.
The VentStar Oxylog 3000 disposable pediatric patient breathing circuit is used with the Dräger Oxylog 3000 and Oxylog 3000 plus Emergency Transport Ventilators for pediatric patients who require ventilation.
Dräger discovered that the check valve on the circuit may leak. This could result in the patient re-breathing exhaled gas with reduced oxygen concentration and increased carbon dioxide levels. This can lead to serious health consequences, including excessive carbon dioxide in the bloodstream (hypercapnia) and increased acidity in the blood (acidosis), which could lead to death.
This issue pertains only to the VentStar Oxylog 3000 Disposable Pediatric Patient Circuit. The catalog number is 5704964. Units were manufactured and distributed from May 2013 to March 2016. The number of devices recalled in the U.S. is 1,530 units.
See the FDA Safety Alert
Also see the Recall
See also Medical Law Perspectives, August 2012 Report: Anesthesiology Errors: Complications, Malpractice, and Catastrophe