The FDA has classified CareFusion’s Sept. 12 recall of 128 EnVe ventilators as Class 1. The company said in a statement that the recall and update affect 29 CareFusion customers who purchased EnVe units that were manufactured between December 2010 and May 2011.
Among the problems cited in the Sept. 12 notification letter were a potential for disconnection during transport, a potential delay in resuming ventilation after reconnection and a potential automatic reset.
San Diego-based CareFusion said it is updating the hardware and software on the affected devices “in a timely manner with minimal disruption to customers.”
Read the recall notification here.