This article was originally published in The Gray Sheet
Executive SummaryGains FDA permission to resume normal distribution of the Life Pulse high frequency jet ventilator. The firm's activities previously had been limited by FDA to shipments to existing customers of supplies and, in emergency situations, ventilators. The shipment restrictions were part of a September 1992 order/agreement with FDA that required Bunnell to recall and retrofit its existing Life Pulse devices ("The Gray Sheet" Sept. 21, p. 28). Bunnell President and CEO Bert Bunnell said in an April 6 press release that "the effect of the FDA enforcement action has been mixed. We have sustained heavy losses in personnel and sales, but our customer base has remained largely intact".
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