Class I Recall Issued for Avea Ventilators

According to the U.S. Food and Drug Administration (FDA), CareFusion has recalled nearly 16,000 Avea ventilators worldwide. The recall has been marked as Class I, which means users are at risk for serious injury or death.

About the CareFusion Ventilator Recall

The recalled Avea ventilator is used to comprehensively care for individuals with respiratory problems. Defective CareFusion ventilators have been used to treat infants, small children, and adults

According to the FDA, the pressure transducer on the machine can fail, causing the device to emit a false alarm. As a result of the false alarm, the units will stop ventilating.

This defect poses a serious threat to people who are dependent on the ventilator for medical reasons. CareFusion has announced that they are sending a letter out to all the consumers who own one of the recalled ventilators.

Description of the Recalled Ventilator

  • According to CareFusion, the recalled ventilator features a user interface screen for consumers to program the necessary medical information
  • The screen sits atop a rolling stand with four legs and measures 16.25 inches wide, 13.75 inches tall, and 2.5 inches deep
  • In addition to the interactive screen and rolling stand, the ventilation system has an internal compression system
  • The compression system weighs about 7 pounds and measures 17 inches wide, 10.5 inches tall, and 16 inches deep
  • The total weight of the ventilator and compression system is 90 pounds
  • The front panel has connection ports for esophageal balloon catheters, tracheal catheters, and proximal flow sensors
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