Home > FDA MedWatch > FDA MedWatch – Oridion Medical and Philips Healthcare Microstream CO2 Filterline (FilterLine H Set Infant/Neonate, VitaLine H Set Infant/Neonate: Recall

FDA MedWatch – Oridion Medical and Philips Healthcare Microstream CO2 Filterline (FilterLine H Set Infant/Neonate, VitaLine H Set Infant/Neonate: Recall

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:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

CLICK HERE to read the MedWatch safety alert, including links to the Class I Recall Notice and press release.

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