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Class I Medical Device Recall: CareFusion EnVe Ventilators

Posted Nov 04 2011 12:00am

Recall Class: Class I

Date Recall Initiated: 9/12/2011

Product(s): CareFusion EnVe Ventilator, model 19250-001.

Range of Manufacturing Dates: The affected products were manufactured between December 2010 and May 2011.

Use: The CareFusion EnVe Ventilator is a portable ventilator used to provide breathing assistance to pediatric and adult patients in hospital and medical transport settings.

Recalling Firm:

CareFusion 203, Inc.
17400 Medina Road, Suite 100
Minneapolis, Minnesota 55447-1341

Reason for Recall: CareFusion has identified potential defects associated with the EnVe Ventilator model 19250-001 that can interrupt ventilation to the patient.

The issues include: a potential delay in resuming ventilation after reconnection; a potential automatic reset; and a potential for disconnection during transport. Failure to adequately ventilate may lead to hypoxia or hypercarbia, which may result in serious neurological injury or death.

Public Contact:

CareFusion is contacting facilities to coordinate hardware and software updates for affected ventilators.

Customers with questions related to this recall may contact CareFusion Technical Support at 1-800-554-8933, Monday through Friday from 8:00 am to 5:00 pm, Pacific Time.

FDA District: Minneapolis

FDA Comments:

On September 12, 2011, CareFusion sent an urgent product recall notification letter to customers by certified mail. The letter provided required action for customers. It also stated that CareFusion would be contacting customers to coordinate a field corrective action to update the hardware and software on affected ventilators.

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.

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