Leadership

FDA Condemns Ventilaide

Issue 8 and Volume 124.

FDA Condemns Ventilaide In a letter to all known purchasers, the Batronic Ventilaide and the Batronic resuscitator are condemned by the United States Food and Drug Administration as “totally worthless for pulmonary ventilation, respiration, or resuscitation.” The letter, signed by Sam D. Fine, associate commissioner for compliance, states, “Because of its worthlessness as a lifesaving measure, we request that you immediately destroy the device(s) in your possession in order that it no longer be available for use.” Fine added in his letter to purchasers that Batrow Laboratories “agreed to withhold distribution of the device.” In a separate letter to Lawrence Hicks, staff director of the Federal Fire Council in Washington, Fine wrote that what he termed the “ineffectiveness” of the Batronic Ventilaide “may serve to delay or deny proper emergency treatment in those life threatening situations where the device is used.”

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