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CareFusion EnVe ventilator recall hit with FDA Class 1 ‘most grave’ designation

(Oct. 19, 2011) CareFusion Corp. today announced that its voluntary recall of 128 EnVe ventilators made late last year through May has received a U.S. Food & Drug Administration designation of Class 1 – meaning the government believes there is a potentially lethal injury risk to patients connected to the affected devices.

According to the San Diego, Calif., manufacturer, the ventilators were recalled for several reasons.

First was the possibility that ventilator settings might unexpectedly change on their own. The fear here was that the patient could receive too little or too much air flow, setting the stage for catastrophe.

There also was the potential that the ventilator’s connections might disengage during transportation, leaving the patient without any breathing support whatsoever.

Further, there were indications that a ventilator mask taken off the patient’s face and then put back on – even if done quickly – might trigger an air-flow failure.

CareFusion said that failure to adequately ventilate a patient can cause serious neurological injury or death from hypoxia or hypercarbia.

The FDA issues Class 1 designations when there is a reasonable probability of serious adverse health consequences or death associated with use of the defective units, the company added..

Not affected by the CareFusion recall are its other products, which include Alaris infusion pumps, Pyxis automated dispensing and patient identification systems, AVEA-, AirLife- and LTV-series ventilation and respiratory products, ChloraPrep products, MedMined services for data-mining surveillance, Nicolet neurological monitoring and diagnostic products, V. Mueller surgical instruments, and an extensive line of other interventional medicine support devices.

The voluntary recall of EnVe ventilators began with the Sept. 12 issuance by CareFusion of an urgent Medical Device Recall Notification to customers. In that notification letter, customers were provided serial numbers of affected devices (this information also is available at www.carefusion.com/customer-support/alerts-notices/medical-device-recall-enve-ventilator.aspx).

According to CareFusion, the 128 EnVe ventilators were sold to 29 customers, chiefly hospitals.

CareFusion said it is conducting a “field corrective action to update the hardware and software on affected ventilators” and that it “determined the root cause for each issue and is committed to updating each device in a timely manner with minimal disruption to customers.”

This, however, is not the first time a CareFusion voluntary recall has drawn a Class 1 designation from the FDA. In October, 2010, the agency classified the recall of approximately 17,000 CareFusion Alaris PC infusion units as a Class 1 recall.

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