A medical device used on newborns and infants who require ventilation is being recalled because a defect may cause serious injury or death, according to an announcement by the Food and Drug Administration (FDA). The Microstream CO2 Filterline is a medical device used by emergency medical services, hospitals and other health service providers to measure exhaled carbon dioxide during ventilation of newborn and infant patients.

The recall was issued because fine plastic strands on the inner surface of the device airway adapter may become dislodged and inhaled by the patient. If these tiny patients breathe in these small plastic strands, their airways can get blocked and they can experience respiratory distress and possibly die.

The recall is classified as a Class 1, which the most serious type of recall the FDA can issue and is only reserved for products in which there is a reasonable probability that use of these products will cause serious injury or death.

The affected products include those made by Oridion Medical and Philips Healthcare. Users of the devices were notified by the manufacturer and told to immediately identify the recalled devices and remove them from their inventory. The devices are to be disposed of in accordance with local regulations.

Any side effects or injuries caused while patients were using these or any other medical devices should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch.

Source: FDA