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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According to the FDA, this is a class III recall which means that use of, or exposure to, the product is not likely to cause adverse health consequences.
In the malfunction report, the company characterized this issue as a Class III recall, which the FDA defines as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Because a product label includes a list of ingredients, nutritional information, safety warnings and other critical consumer information, a misprinted label signifies a communication error that most often results in a Class III recall under the direction of the FDA.
The presence of a non-allergen that is generally recognized as safe will result in a Class III recall.
72) Class III recalls involve products that will not cause adverse health consequences.
Public notice of Class III recalls is usually limited to an RNR on the FSIS website.
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.
The FDA said the Class III recall was initiated by Abbott by letter dated December 22, 1999.
FDA's regulations tend to suggest Class III recalls may not be needed, as they state FDA will not request a recall unless the product in question "presents a risk of illness or injury or gross consumer deception.