7/3/2012 9:01:10 AM
SAN DIEGO, July 2, 2012 /PRNewswire/ -- CareFusion issued the following update regarding its voluntary recall of its AirLife Infant Breathing Circuit. The FDA has classified this action as a Class 1 recall.
The company initiated the voluntary recall on May 29. The products subject to the recall were manufactured between June 1, 2010, and Feb. 3, 2012. This action has no effect on the manufacture or distribution of current products.
In May 2012, the company sent an urgent Recall Notification to customers and distributors stating 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. A Class I recall is defined as a reasonable probability of serious adverse health consequences or death associated with use of the defective units. To date, there have been no reports of patient harm associated with the affected products.
There is no change to the remediation plans previously announced by the company. In the notification letter, customers were provided lot numbers of affected product codes and asked to destroy any affected products remaining in inventory. This information is available 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, nearly half of the affected customers and distributors have completed the remediation process.
Instructions to customers
Customer inquiries related to this action should be addressed to CareFusion Customer Service at Customer.Experience@carefusion.com.
Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA's MedWatch Program: by mail at MedWatch, HF-2, FDA 5600 Fishers Lane, Rockville, MD 20852-9787; by phone at 1-800-332-1088; by fax at 1-800.FDA.0178 or at www.fda.gov/medwatch.
Additional product recall information
CareFusion has posted on its website information regarding the AirLife product recall and other product recalls and alerts. Also today, the company separately filed with the Securities and Exchange Commission a Form 8-K in which the company reported an expected increase to its recall reserve of approximately $7 million for the quarter and fiscal year ended June 30, 2012. This adjustment is primarily related to a voluntary recall affecting the PC unit of certain models of the company's Alaris® infusion pumps. More information can be found on the company's website at http://www.carefusion.com/customer-support/alerts-notices/medical-device-recall-alaris-8015.aspx.
CareFusion (NYSE: CFN) is a global corporation serving the health care industry with products and services that help hospitals measurably improve the safety and quality of care. The company develops market-leading technologies including Alaris® infusion pumps, Pyxis® automated dispensing and patient identification systems, AVEA®, AirLife and LTV® series ventilation and respiratory products, ChloraPrep® products, MedMined® services for data mining surveillance, V. Mueller® surgical instruments, and an extensive line of products that support interventional medicine. CareFusion employs more than 14,000 people across its global operations. More information may be found at www.carefusion.com.