Ventlab Adult and Pediatric Manual Resuscitators have been recalled because a valve leak prevents the flow of air/oxygen to the patient, the U.S. Food & Drug Administration (FDA) just announced.
The affected manual resuscitators may have a valve leak that prevents the flow of air/oxygen to the patient and may not be easily observable to the user because the bag still deflates when compressed. Lack of air/oxygen can cause life-threatening health consequences for patients, including hypoxia, hypoventilation, or death. No injuries have been reported, to date.
The recalled Ventlab Adult and Pediatric Manual Resuscitators are often used in health care facilities and by emergency medical services during patient transport or as a backup to ventilators and anesthesia machines.
The defective Ventlab Adult and Pediatric Manual Resuscitators were manufactured and distributed between March 2012 and July 2012. Products can be identified by the part number, description, and lot number on case labels, as well as a small white label on the individual packaging bag. A detailed list of the recalled Ventlab resuscitators may be accessed at http://www.fda.gov/Safety/Recalls/ucm324561.htm.
Ventlab notified customers of this recall in a letter sent June 10, 2012. Customers were asked to check their facility’s inventory for the affected products and complete and return the response form that was included with the letter and to indicate whether or not their facility was in possession of the affected products. Ventlab Corporation is in the process of arranging for the return and replacement or repair of the manual resuscitators affected by this recall. Ventlab Corporation may be reached, toll-free at 1.800.593.5654 between 8:30 a.m. and 5:00 p.m., Eastern Standard Time, Monday through Friday, and by email at [email protected].
Serious adverse events and product quality problems should be reported to the FDA MedWatch program at www.fda.gov/medwatch/report.htm.