FDA response to HRG
This article was originally published in The Gray Sheet
Executive Summary
FDA's device center defends categorization of five Class II recalls in a May 18 response to Public Citizen's Health Research Group, which had questioned the classification of the recalls in a May 7 letter ("The Gray Sheet" May 17, p. 18). The device center explains that recalls of Infrasonics' Adult Star ventilator, Theratronics' Therac Model 20 (T20) linear accelerator, Gambro Lundia AB's Bicarbonate Control Monitors, Pacific Communication's Central Telemetry Systems for arrhythmia detection and Sarns/3M's MDX battery pack were deemed Class II because the device problems presented low or moderate risk of significant adverse health consequences.
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