Respironics Issues Worldwide Recall of PLV Continuum Ventilator

Date of Recall

2006-05-05

Recall Details

Murrysville, PA -- May 5, 2006 -- Respironics, Inc. announced today that it has voluntarily recalled 269 ventilators representing all models and serial numbers of the PLV® Continuum™ Ventilator. This recall is being conducted because the ventilator may suddenly stop providing mechanical ventilation. This could result in serious injury or death. The recalled ventilators should not be used until the problem is corrected. Customers have been directed to quarantine all PLV Continuum Ventilators and to use other ventilator models. If a customer does not have a suitable substitute ventilator, Respironics will loan them a comparable unit.

The PLV Continuum Ventilator is used to provide mechanical ventilation for pediatric and adult patients who weigh at least 5 kg (11 lbs.). The device is intended for use at home, in an institution, or as a portable ventilator. These ventilators have been distributed in the United States, Australia, Argentina, Canada, Japan, Hong Kong, Netherlands, Saudi Arabia, and Taiwan. Respironics provided notification of the recall to distributors, sales personnel, and customers by letter on March 20, 2006. The firm is continuing to contact customers to arrange for the return of all the recalled ventilators.

Respironics identified the problem after an analysis of returned units revealed the potential for failure of an internal flow valve. The Company has received no reports of adverse events or injuries resulting from this problem. Respironics notified the U.S. Food & Drug Administration (FDA) of its decision to voluntarily recall the product. The recall was classified as a Class I Recall by the FDA on April 27, 2006. A Class I recall is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. Customers with questions may contact the Company at 877-544-9252.

Any adverse reactions experienced with the use of this product, and/or quality problems should also 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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