CareFusion, 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 recall only affects EnVe ventilators manufactured between December 2010 and May 2011.
On September 12th, 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. 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.
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.
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