Tuesday, June 7, 2011

Philips Healthcare recalls breathing device for babies

By Julie M. Donnelly, Boston Business Journal

Andover-based Philips Healthcare has recalled specific lots of infant and neonatal-sized ventilation devices because dislodged plastic strands may be found within the airway adapter which may then become inhaled by the patient. The devices are used by health care providers to measure exhaled CO2 during ventilation of infants.

Affected products include Philips FilterLine H Set and VitaLine H Set Microstream carbon dioxide (CO2) sampling lines shipped from November 2010 through March 2011.

Philips said it initiated the recall in April 2011, after being informed by the manufacturer of these devices, Oridion Systems Ltd. (Nasdaq: ORDN), about the defects.

To date, Philips has not received any reports of injuries related to this issue, the company said. However, inhalation of the plastic strands on the defective devices may cause respiratory compromise, which could result in serious illness or death, the company said.

Philips said it has already notified all known users of the affected Philips-labeled devices in the U.S. and instructed them to dispose of the affected units.

In January 2010, the company voluntarily recalled its Avalon Fetal Monitors because of complaints concerning inaccurate fetal heart-rate readings during ultrasound procedures.