The U.S. Food and Drug Administration announced earlier this month that it has notified healthcare professionals of a Class I recall of the GE Healthcare Vital Signs Hygroscopic Condenser Humidifier Passive Humidification Device for Vital Signs Anesthesia Breathing Circuits.
The Class I recall, the FDA's most serious, confirms the concerns the FDA has about the product, which is sold as a part of the Vital Signs anesthesia breathing circuit and is used to maintain moisture in the patient's airway during mechanical ventilation. Reports say the affected products were manufactured between January 2011 and April 2011, and a list of affected product codes and lot numbers can be accessed at on the FDA website.
GE began notifying customers with affected units in April of 2011, reports say, and doctors, hospitals and other customers are also directed to remove and return all affected products.
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