Philips Healthcare has initiated a voluntary global recall of devices to measure carbon dioxide (CO 2) exhaled by infant and neonatal patients, due to concern that patients could inhale dislodged plastic strands found in defective products, which could result in serious injury or death.
The North Andover, Mass.-based company commenced the recall of infant and neonatal-sized Filterline H Set and Vitaline Sampling Lines in April, after the manufacturer, Oridion Systems, informed them that a production issue affected certain lots. The affects lots of the CO 2 sampling lines were shipped from November 2010 through March 2011.
The devices are used to take small breath samples from intubated infants and neonatal patients and are part of a larger ventilation system.
“We have contacted customers to let them know about the recall and are working with them to stop use of the product and provide them with new product when it’s available,” said Philips spokesperson Ian Race. “Due to the sensitivity of the patient populatation, we want to do anything we can to ensure the quality and safety of the product.”
According to Race, Philips had just more than 1,000 boxes of the product, each containing 25 of the devices, which are manufactured by Oridion and then distributed by Philips.
To date, Philips has not received any reports of injuries related to the issue, but the inhalation of the plastic strands, about the thickness of a human hair, could cause serious injury or death.