FDA posts Class 1 recall for Dräger’s pediatric breathing circuit with leaking problems
The Food and Drug Administration (FDA) has issued a Class 1 recall alert, its most serious recall classification, for Dräger’s VentStar Oxylog 3000 Disposable Pediatric Patient Circuit due to a leaking issue which could kill patients.
According to the FDA, the issue is with the device’s check valve. Leaks there could lead to patients re-breathing exhaled gas, which can lead to serious conditions such as excessive carbon dioxide in the bloodstream (hypercapnia) and increased acidity in the blood (acidosis).
The device is used with the Dräger Oxylog 3000 and Oxylog 3000 plus emergency transport ventilator, which had already been the subject of a Class 1 recall in December 2015. Its most likely to be found in emergency transports, emergency departments, and recovery rooms.
The recall was first initiated by the company on May 31. 1,530 of the potentially defective units were distributed between March 2013 and May 2016 in 26 states: Alaska, California, Florida, Indiana, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Mississippi, Minnesota, Missouri, Montana, North Carolina, New Hampshire, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin.
John joined TriMed in 2016, focusing on healthcare policy and regulation. After graduating from Columbia College Chicago, he worked at FM News Chicago and Rivet News Radio, and worked on the state government and politics beat for the Illinois Radio Network. Outside of work, you may find him adding to his never-ending graphic novel collection.