In June Carefusion issued two recall notices, one pertaining to its AirLife™ infant breathing circuit, here, the other to its Enve ventilators, here. Now the company has issued the following update regarding the EnVe® ventilators.
The FDA has classified this action as a Class 1 recall, which it issues when a reasonable probability of serious adverse health consequences or death associated with use of the defective units has been identified.
Enve ventilator products subject to the recall were manufactured between December 2010 and January 2012, this action having no effect on the manufacture or distribution of current products.
In June, CareFusion sent an urgent Recall Notification to customers stating that the company had identified potential risks associated with the EnVe ventilator. The problem is identified as the potential for a leak to occur in the patient breathing circuit of the system, resulting in the ventilator not holding the set Positive End Expiratory Pressure (PEEP) value either intermittently or continuously.
The device will activate both audible and visual alarms to notify the health care professional that ventilation delivery to the patient may be compromised.
Carefusion says remediation plans previously announced by the company are underway and will be completed at customers’ sites.
To date, there have been no reports of patient harm associated with the affected devices.
SOURCE CareFusion Corporation, PR Newswire