The U.S. Food & Drug Administration (FDA) just deemed the CareFusion AirLife Infant Breathing Circuit recall a Class I, its most serious designation and one that defines the risk of using the recalled device as presenting a reasonable likelihood of serious adverse health consequences or death.
The company initiated the voluntary recall on May 29, sending an urgent Recall Notification to customers and distributors that stated the identified potential risks associated with the AirLife Infant Breathing Circuit. The Y-adapter in affected products could develop cracks during patient use, potentially resulting in a leak in the closed ventilation system and leading to a loss in the intended tidal volume delivered to the patient. To date, there have been no reports of patient harm associated with the affected products.
The recalled CareFusion AirLife Infant Breathing Circuit devices were manufactured between June 1, 2010, and Feb. 3, 2012. Manufacture or distribution of current products is not impacted. Also, there is no change to the remediation plans previously announced by the company.
In the May notification letter, customers were given the lot numbers of affected product codes and asked to destroy any affected products remaining in inventory. This information is available at on the CareFusion web site at: http://www.carefusion.com/customer-support/alerts-notices/medical-device-recall-for-airlife-infant-breathing-circuit.aspx. Since the recall was initiated in May, almost half of the affected customers and distributors have completed the remediation process.
Customer inquiries should be addressed to CareFusion Customer Service at [email protected]. Adverse reactions experienced with the use of this product, and/or quality problems, should be reported to the FDA’s MedWatch Program: By mail at MedWatch, HF-2, FDA 5600 Fishers Lane, Rockville, MD 20852-9787; by telephone at 1.800.332.1088; by fax at 1-800.FDA.0178; or online at www.fda.gov/medwatch.
This is not the first time that CareFusion devices were involved in a recall deemed a Class I by the FDA. Earlier this year, we wrote that CareFusion NicoletOne Software and Nicolet devices were named in a Class I recall. The recalled devices and associated software are used for functional brain mapping procedures by physicians and surgeons who treat patients diagnosed with seizure disorders and brain tumors. Recall issues may result in the surgeon resecting the wrong brain tissue or may cause the surgeon to fail to resect pathological tissue.
Prior to that we wrote that in three separate actions, CareFusion updated its AVEA® ventilator recall; that certain CareFusion EnVe Ventilators were recalled; and that CareFusion issued a recall for some of its Alaris PC Units electronic infusion devices. All three actions were deemed Class I recalls by the FDA.