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Recall of Infant and Neonatal-Sized FilterLine H Set and VitaLine H Set Sampling Lines

Posted May 20 2011 9:14pm
FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

Steve Kelly
Phone: +1 (425) 487-7479

Ian Race
Phone: +1 (978) 659-4624

FOR IMMEDIATE RELEASE - May 20, 2011 -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.

M1923A  Philips Filterline H Set Infant/Neo  M8330M10      M8386N10      M8411P10      M8451P10      M8477A11      M8514A11      M8572B11 989803159581 Philips Vitaline H Set Infant/Neo  M8409P10
Product  Product Description Product Lot Codes

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 . 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 .

For media inquiries, please contact:
Steve Kelly
Philips Healthcare
Tel: +1 (425) 487-7479

Ian Race
Philips Healthcare
Tel: +1 (978) 659-4624

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