The U.S. Food and Drug Administration (FDA) has issued two Class I recalls, indicating a risk of serious injury or death to patients, for two ventilator-related products:
Ventlab Corporation’s adult and pediatric manual resuscitator, manufactured and distributed between March and July 2012, is being recalled due to a defective valve. The valve can leak preventing the patient from receiving air or oxygen required. The reduction in airflow may not be easily detected because the resuscitator’s bag continues to deflate when compressed. These manual resuscitators are used for both adults and children by emergency medical services during patient transfer and as back-up to ventilators and anesthesia machines. The lack of oxygen can cause life-threatening health situations to patients, including hypoxia, hypoventilation and/or death.
A voluntary recall of 14,602 Ventlab manual resuscitators was previously announced and begun in July 2012. Consumers may contact Ventlab Corporation of Mocksville, South Carolina, at 1(800)593-5654 between 8:30 a.m. and 5 p.m. (EST), Monday through Friday, or email the company at csr@ventlab.com Ventlab is in the process of arranging for the return and replacement or repair of the manual resuscitators affected by this recall. The models numbers and quantities of Ventlab Resuscitators affected by the recall can be found in the announcement on the FDA’s website, www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm333255.htm and clicking on “Affected Model Lot and Serial Numbers…” for Ventlab Corporation Adult and Pediatric Manual Resuscitators.
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Bunnell’s Life Pulse High-Frequency Ventilator Patient Circuits, distributed between March 19, 2012 and November 1, 2012, are being recalled. There have been 12 reported failures of 5,743 Patient Circuits distributed, and no reports of patient injury or death. The heater wire insulation on the product can melt, causing sparks and smoke close to the humidifier cartridge. The device is used for critically ill infants with pulmonary interstitial emphysema or respiratory distress syndrome and who are failing when conventional ventilation is used. The company, Bunnell of Salt Lake City, Utah, notified its customers in November of an urgent recall. A complete list of Lot numbers affected by the Class I recall is identified in the recall notice on Bunnell’s website, www.bunl.com
Customers with questions can contact Bunnell at 1(800)800-4358 ext. 6, from 8 a.m. until 4 p.m. (MST) Monday through Friday or via email to plattdr@bunl.com
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