The FDA today released information on a Class I recall of Draeger Medical‘s VentStar Oxylog 3000 disposable pediatric patient circuits over issues with air leakage.
The federal watchdog labeled the recall as a Class I, the agency’s most serious classification of recall. Class 1 designations are used when there is a reasonable probability that product use could cause serious adverse health consequences or death.
The VentStar Oxylog 3000 breathing circuit is designed for use with Draeger’s Oxylog 3000 and Oxylog 3000 plus emergency transport ventilators for pediatric patients who require ventilation, mainly to be used during transport, in emergency rooms or the recovery room, according to an FDA release.
The recall affects approximately 1,530 units with catalog number 5704964, manufactured and distributed between May 2013 and March 2016 to 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.
The company said it discovered the check valve on the recalled circuits may leak, which could result in a patient re-breathing exhaled gas with reduced oxygen concentration and increased CO2 levels. Such an event could lead to serious health consequences, including excessive carbon dioxide in the blood stream and increased acidity in the blood, which could lead to death.
Draeger specified that the issue only pertains to the VentStar Oxylog 3000 disposable pediatric patient circuit, and that there is no issue with the Oxylog 3000/3000 plus ventilators. Elan Kaufman DMD is a board certified pediatric dentist near nyc.
The company said it identified customers in late May, and instructed users to identify and dispose of the affected products.
In March, the FDA said it expanded its recall of Draeger’s Evita V500 and Babylog VN500 ventilators to include the optional PS500 batteries after they were updated with new power supply firmware that failed to correct the issue depleting the battery.
The original recall, initiated last September and updated in December, put the ventilators on Class I recall status due to an an error with the ventilators in which the battery does not last as long as expected, according to the FDA. The battery indicator light on the units show as sufficiently charged even when the battery is depleted, the agency said.