The FDA sent a notice of a Class I Recall, initiated July 11, 2012, of the Ventlab Corp adult and pediatric disposable, manual resuscitators.
Manufactured and distributed between March 2012 and July 2012, the affected manual resuscitators are disposable devices used to provide temporary breathing support to adult and pediatric patients who cannot breathe on their own.
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 company recalled the affected manual resuscitators because they may have a valve leak that 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.
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