Respironics Issues Worldwide Recall of PLV Continuum Ventilator
Respironics, Inc. has voluntarily recalled 269 PLV Continuum ventilators (PLVC I) representing all models and serial numbers of that product. The devices may suddenly stop providing mechanical ventilation because of failure of an internal flow valve. The recall was classified as a Class I Recall by the FDA on April 27, 2006 since such a failure could lead to serious injury or death. The company can be contacted at 877-544-9252. This product is used with children above 11 lbs. (5 kg) and adults, at home and in institutions or as a portable ventilator. Recalled ventilators are not to be used until the problem is corrected.
See today’s press release, March 20 Class 1 Medical Device Recall, product announcement from July 2005 and brochure (pdf).
May 5, 2006 Related topics: Product Recalls