Recall Class: Class I

Date Recall Initiated: August 5, 2014

Products: CareFusion 203, EnVe and ReVel ventilators

• Manufacturing Dates: May, 2009 - August 2014
• Distribution Dates: December 10, 2010 - August 6, 2014.
• Complete Listing of Affected Lot Numbers [there are 3 pages of serial numbers]

Use: The CareFusion EnVe and ReVel ventilators are used on patients who require respiratory support or mechanical ventilation and weigh a minimum of 11 pounds (5 kg).  They are used in hospitals, during transport of a patient and at home to provide constant or intermittent respiratory support.

Recalling Firm:
CareFusion 203, Incorporated
17400 Medina Road, Suite 100
Minneapolis, Minnesota 55447-1341

Reason for Recall:

CareFusion 203 recalled these devices because of the potential for damage to their power cord adaptors which can cause loss of power and complete shut off.

The EnVe and ReVel ventilators can be operated using either batteries or external power sources (AC or auto lighters). The firm recalled these devices because they found that the pins of the external power connector did not always align properly with the input port of the ventilator. This misalignment can damage the pins on the connector and possibly short circuit the ventilator. A short circuit in the power supply may prevent the ventilator battery from recharging, and the ventilator could lose power unexpectedly. Ventilator shut-off from power failures may lead to serious patient injury or death.

The company has received 256 reports of the incident with no reported injuries or deaths.

Public Contact: For questions regarding the operation and/or servicing of affected CareFusion ventilators in the United States, call the CareFusion Recall Center at 888.562.6018, Monday through Friday, 7:00 a.m. – 4:00 p.m., Pacific Time or via email at SupportCenter@carefusion.com.

FDA District: Minneapolis District Office

More information about this Recall:

CareFusion sent customers a Product Recall Notice letter on August 8, 2014. The letter identified the product, problem and actions to be taken. The letter also said that two new power adaptor accessory kits for the ReVel and EnVe ventilators would be sent to correct the problem.

CareFusion recommends that the user:

1. Plug in the new AC Power Adapters and return a confirmation for each one used.
2. Identify the ventilator serial numbers and/or serial numbers of AC Power Adapters, and Auto Lighter Power Cords which have been attached.

About Class I Recalls:

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.