The FDA today issued a recall for Dräger Medical‘s emergency transport ventilators over a system error that can lead to a a halt in ventilator function, labelling the recall as Class I.
The FDA labels recalls as Class I, the agency’s most serious classification of recall, when there is a reasonable probability that product use could cause serious adverse health consequences or death.
The ventilators are being recalled over an electrical issue that may cause the units to stop working if the control knobs are not regularly used, the federal watchdog said. If the device operator fails to intervene, the patient may not receive sufficient oxygen and could suffer adverse health consequences, such as injury or death.
A total 117 units are being recalled, distributed across 39 states. The recall affects Dräger’s Oxylog 2000 plus, Oxylog 3000 and 3000 plus ventilators.
Catalog numbers 5705080, 2M86300, 2M86965, 5704813 and 5704831, distributed between April 1, 2007 and December 12, 2015 were identified by the FDA in the recall.
The FDA said Dräger sent out letters in December warning customers with the devices about the issue. The letter instructed operators to turn the device off and rotate all control knobs at least 10 times to the left and right stop.