A recall has been issued for several models of Microstream CO2 Filterline medical devices, which are used to measure how much carbon dioxide is exhaled by infants and newborns during ventilation.
The Microstream CO2 Filterline recall was first announced to distributors and customers by Oridion Medical in April, but on Monday the FDA classified it as a Class 1 medical device recall, meaning that the agency believes the defective device has a probability of causing serious injury or death.
Fine plastic strands on the inner surface of the infant airway adapter of the Microstream CO2 Filterline may become dislodged and inhaled by the babies, potentially causing respiratory problems that may lead to serious injury or death. However, there have been no injuries or deaths reported to date in connection to the recall.
The recall affects Microstream Co2 Filterlines (FilterLine H Set Infant/Neonate, VitaLine H Set Infant/Neonate) by Oridion Medical with model numbers 006324 and 010807, and by Philips Healthcare with model numbers M1923A and 989803159581. The devices affected by the recall were manufactured and distributed between October 2010 and February 2011. A full list of lot numbers is available in the FDA Class 1 medical device recall notification.
Both companies are in the process of notifying customers worldwide. Phillips Healthcare has notified all users of its affected devices in the U.S. Oridion Medical customers with affected devices can contact Oridion at 1-888-674-3466 ext. 1234 for more information. Phillips Healthcare customers with questions can contact David Rowe at 1-978-659-3021.