Pharmaceutical

Infant ventilator device recalled due to serious defect

preemie baby 435x293 Infant ventilator device recalled due to serious defectCareFusion is recalling several lots of the Airlife Infant Breathing Circuit, a device used with a ventilator when mechanical ventilation is required, because of a defect that could cause a potentially life-threatening safety risk to patients.

The Airlife Infant Breathing Circuit has a Y adapter within it that may spontaneously crack, causing a leak in the closed ventilation system. This leak could lead to a decrease in the tidal volume delivered to the ventilated patients.

This recall is classified as a Class 1, which is the most serious type of recall and involves situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

CareFusion informed its customers and distributors of the defect. Distributors were told to immediately destroy any affected products currently in stock at their facilities and to cease distributing the products. They were also asked to forward the recall notice to customers who purchased the devices and inform them of the potential risk. The customers were instructed to return any unused product to the distributor.

The recall includes all lot numbers less than lot #0000414257 or beginning with the letter “Y” for all product codes manufactured prior to February 3, 2012.

Health care professionals and consumers who have experienced any adverse reactions or quality problems with this or any other medical device should report it to the Food and Drug Administration MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.

Source: FDA