May 20, 2011
Recall of Infant and Neonatal-Sized FilterLine H Setand VitaLine H Set Sampling Lines
Andover, Mass. – Philips recently recalled specific lots of infant and neonatal-sized Philips FilterLine H Set and VitaLine H Set Microstream carbon dioxide (CO2) sampling lines shipped from November 2010 through March 2011.
Philips initiated the recall in April 2011 after being informed by the manufacturer of these devices, Oridion Systems Ltd., that due to a production issue affecting certain lots, it was recalling these products, which it also markets under its own name.
Description of the problem
These devices are used by emergency medical services, hospitals, and other health care providers to measure exhaled CO2 during ventilation of infants and neonates. According to Oridion, the manufacturer of the devices, dislodged plastic strands may be found within the airway adapter which may then become inhaled by the patient. The strands are typically 5 mm long and 100 microns in diameter, about the thickness of a human hair.
To date, Philips has not received any reports of injuries related to this issue. However, inhalation of the plastic strands on the defective devices may cause respiratory compromise, which could result in serious illness or death.
Recommended action to be taken by the user
Philips has already notified all known users of the affected Philips-labeled devices in the U.S. and is in the process of notifying all customers world-wide. In its recall communication, Philips instructed users to immediately identify all products from affected lots, remove them from inventory and dispose in accordance with local regulations. More information about specific manufacturing lots subject to this recall may be found at http://www.philips.us/filter. New products are being supplied to affected customers at no charge.
Philips has notified the FDA of its decision to voluntarily recall the affected product. Customers who have questions about the recall or wish to report product problems may contact their local Philips Representative.
Any adverse events experienced with the use of this product should be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.
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Field Safety Notice