Respironics Class I recall
This article was originally published in The Gray Sheet
Executive Summary
Firm announces voluntary recall of 5,293 ComfortGel sleep apnea nasal masks distributed from Sept. 5-15 because some products were shipped without an exhalation port for carbon dioxide. Without the port, patients could experience oxygen deficiency or suffocation, the Murrysville, Penn. firm says Dec. 3. Respironics alerted FDA of the issue in September, and maintains that 82% of the recalled masks have returned with less than 3% affected. The company initiated a Class I recall for computer-controlled ventilators this summer (1"The Gray Sheet" July 7, 2003, In Brief)...
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