Philips recently recalled specific lots of infant and neonatal-sized P<"https://www.yourlawyer.com/practice_areas/defective_medical_devices">hilips FilterLine H Set and VitaLine H Set Microstream carbon dioxide (CO2) sampling lines shipped from November 2010 through March 2011, the US. Food and Drug Administration (FDA) just announced.
The defective products, product numbers, and lot codes are:
â€¢ Philips FilterLine H Set Infant: Product number M1923A; product lot codes: M8330M10, M8386N10, M8411P10, M8451P10, M8477A11, M8514A11, and M8572B11.
â€¢ Philips VitaLine H Set Infant/Neo: Product number 989803159581; product lot code M8409P10.
Philips initiated the recall in April 2011 after being informed by the manufacturer of these devicesâ€”Oridion Systems Ltd.â€”that, due to a production issue affecting certain lots, it was recalling these products, which it also markets under its own name.â€¨
Emergency medical services, hospitals, and other health care providers use these devices to measure exhaled CO2 during ventilation of infants and neonates. According to Oridion, 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. Inhalation of the plastic strands on the defective devices may cause respiratory compromise, which could result in serious illness or death.
Philips has 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 them in accordance with local regulations. More information about specific manufacturing lots subject to this recall may be found at http://www.philips.com/filter.
New products are being supplied to affected customers at no charge. Customers with questions about the recall or who wish to report product problems may contact their local Philips Representative.â€¨
Any adverse events experienced with the use of this product should be reported to the FDAâ€™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.