Oridion Medical and Philips Healthcare Microstream CO2 Filterline (FilterLine H Set Infant/Neonate, VitaLine H Set Infant/Neonat
Posted Jun 07 2011 9:30am
AUDIENCE: Emergency Medicine, Pediatrics
ISSUE: Fine plastic strands on the inner surface of the infant/neonatal airway adapter may become dislodged and inhaled by the patient. Inhalation of the plastic strands on the defective devices may cause respiratory compromise, which could result in serious illness or death.
BACKGROUND: The Microstream CO2 Filterline is a medical device used by emergency medical services, hospitals, and other health care providers to measure exhaled carbon dioxide (CO2) during ventilation of newborn and infant patients. See the recall notice for affected models and lots.
RECOMMENDATION: Philips instructed users to immediately identify all products from affected lots, remove them from inventory and dispose in accordance with local regulations.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: