Skip to content
Shipping Worldwide
Shipping Worldwide

Oct 19, 2011 - CareFusion Initiates Class I Recall of EnVe Ventilators

CareFusion Initiates Class I Recall of EnVe Ventilators

Oct. 19, 2011 /PRNewswire/ -- CareFusion (NYSE: CFN), a leading global medical device company, issued the following update regarding its recall of 128 EnVe™ ventilators affecting 29 customers. The FDA has classified this action as a Class I recall.

The voluntary recall only affects EnVe ventilators manufactured between December 2010 and May 2011 and therefore, has no affect on the company's current product production or shipping processes.

On September 12, the company sent an urgent Medical Device Recall Notification to customers stating the identified potential risks associated with the EnVe ventilators. The issues include: a potential delay in resuming ventilation after reconnection; a potential automatic reset; and a potential for disconnection upon transport. Failure to adequately ventilate may lead to hypoxia or hypercarbia, which may result in serious neurological injury or death. A Class I recall is defined as a reasonable probability of serious adverse health consequences or death associated with use of the defective units.

In the notification letter, customers were provided serial numbers of affected devices. This information is available at http://www.carefusion.com/customer-support/alerts-notices/medical-device-recall-enve-ventilator.aspx.

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

Instructions to customers

Customer inquiries related to this action should be addressed to CareFusion Technical Support at 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.

SOURCE CareFusion

This collection is empty

Contact Us

Reviews

What our customers are saying

C. Lopez

Arrived very quickly. It was just what I was looking for and with a more approachable value.

Norman F

Great timely service, will use again.

Mark F

Great replacement battery!, it even has an expiration on it so that I know when to change it in 5 years. Last ones I purchased from another seller was garbage.

A.C.

Good turn around time

S.T.

Great product and service

R Harrison

Everything is as expected.

Email
1 (888) 228-7564