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Ventlab Adult and Pediatric Manual Resuscitators: Recall-Valve Leak Prevents Flow of Air/Oxygen to Patient

Friday, December 21, 2012

Audience: Risk Manager, Anesthesiology

ISSUE: The affected manual resuscitators may have a valve leak which prevents the flow of air/oxygen to the patient. This lack of airflow to the patient 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.

BACKGROUND:  These devices 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 affected manual resuscitators were manufactured and distributed between March 2012 and July 2012. The affected model and lot numbers can be found in the firm's press release.

RECOMMENDATION: The company notified customers of this recall in a letter sent June 10, 2012. Customers were requested to check their facility’s inventory for the affected products and complete and return a response form, included with the letter, to indicate whether or not their facility had any of the affected products. Ventilab Corporation is in the process of arranging for the return and replacement or repair of the manual resuscitators affected by this recall.



Read the complete MedWatch Safety Alert, including a link to the Recall Notice, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm333261.htm

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