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Class III Recall

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Class III Recall
A situation in which use of or exposure to a violative product is not likely to cause adverse health consequences


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This regulation categorizes product recalls into three classifications: A Class I recall means the use of the medical device could result in serious damage to health; a Class II recall implies that use of the medical device could induce temporary or recoverable health damage; and a Class III recall indicates that use of the device generally does not inflict danger to health, and other factors most likely led to the recall.
Class III recalls declined to 60 this year from 110 the prior fiscal year.
FDA acknowledged that Radiometer America's June 5-response letter stated the firm has revised its Corrections and Removals Procedure so that they require all recalls, including Class III recalls, are reported to FDA.
 
 
 
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