FDA Upgrades CareFusion Ventilators Recall to Class 1

In a press release, the US Food and Drug Administration (FDA) announced the upgrade in classification of the recall for CareFusion Corp’s EnVe ventilator units to Class-1, the most severe designation given by the agency.

CareFusion, a drug-delivery systems and respiratory equipment manufacturer, initiated a voluntary recall of the ventilator units last months due to an issue with potential disconnection during transport. A notice was sent to 29 customers in pediatric and adult critical care. The failure to adequately ventilate patients with severe respiratory problems could potentially result in serious neurological injury or even death. The recall affects only the EnVe ventilator units manufactured in the period between December 2010 and May 2011. CareFusion is currently working to correct and update the hardware and software on the affects units.

Class-1 recall designations are issued in situations where the agency finds there is reasonable probability that use of or exposure to the recalled product could cause severely adverse health consequences or death.

As a Vancouver personal injury lawyer, I’ve seen recalls similar to this in the past and know the dangers these defective products pose to consumers. I hope that by making this information more readily available, potential injury can be avoided in the future. If you’ve been injured through the use of a defective medical device, it may be in your best interests to speak with an experienced personal injury lawyer in your area.