CareFusion AirLife Recall Issued For Infant Breathing Circuit
Federal regulators are have determined that a recalled infant ventilator system sold by CareFusion poses a substantial risk of serious injury or death for children.
A CareFusion Airlife Infant Breathing Circuit recall issued in May, was classified by the FDA as a Class I medical device recall earlier this week.
The designation, which is the most serious category for a medical device recall, suggests that the agency believes that problems with the infant ventilators could pose a major risk, although there have been no injuries reported in connection with the device so far.
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CareFusion first sent a letter to customers (PDF) at the end of May, warning that they were recalling AirLife because of complaints involving cracks in a Y adapter within the breathing circuit that occurred during patient use. The company warned that the cracks could potentially lead to a leak in the closed ventilation system, reducing airflow to the child.
The company notes that the ventilators have an alarm to warn if airflow decreases and the alarm has worked as it should in every reported instance of problems.
The recall affects all AirLife Infant Breathing Circuits with lot numbers less than #0000414257 or that begin with the letter ‘Y’. The recall does not affect any products with a lot number higher than that number.
The company is recommending that its customers not use any affected ventilators and requests that they be destroyed instead of being returned to the company. Customers were provided with a form to fill out when the device had been destroyed and will get credit for destroyed products.
This is the second major ventilator recall for CareFusion in less than a year. In December, a CareFusion AVEA Ventilator recall was announced after nearly 100 reports of malfunctions. The most common problem reported was that the AVEA ventilator activated a false, extended high peak alarm, which then opened the safety valve and stopped the units from ventilating.
Customers with questions about the latest recall can contact Dave Wehrheim at CareFusion at David.Wehrheim@CareFusion.com, or by calling (847) 473-7495.
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