CareFusion Provides Update On Voluntary Recall Of EnVe Ventilator

CareFusion issued the following update regarding its previously announced voluntary recall of EnVe ventilators. The FDA has classified this action as a Class 1 recall.

The company initiated the voluntary recall in June. The products subject to the recall were manufactured between December 2010 and January 2012. This action has 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. A leak may occur in the patient breathing circuit or 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. A Class I recall is defined as having a reasonable probability of serious adverse health consequences or death associated with use of the defective units.

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.

Instructions to customers
Customer inquiries related to this action should be addressed to the CareFusion Customer Support Center at 1.800.554.8933.

Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA's MedWatch Program: by mail at MedWatch, HF-2, FDA 5600 Fishers Lane, Rockville, MD 20852-9787; by phone at 1.800.332.1088; by fax at 1-800.FDA.0178 or at www.fda.gov/medwatch.