We're doing our annual mock recall exercise, and need a bit of help determining the recall class for our mock scenario.
Mock recall exercise scenario: During a PCO the crosscut slicer's stainless-steel blades were found damaged. Small pieces, or blade shavings, may have entered finished product. Metal detector would not have alarmed if SS piece is <5.0mm (our validated critical limit for SS). The finished products are ready-to-eat crosscut pickles in bulk packaging, intended for foodservice. Our direct customers are foodservice distributors.
This is where our team is getting a bit stuck: the quote below states that objects <7mm rarely cause serious injury or trauma except in special risk groups. Does that mean that in our mock scenario above, it would be a Class II (may cause temporary or medically reversible health consequences, probability of serious adverse health consequences is remote) recall rather than Class I (reasonable probability that use or exposure will cause serious adverse health consequences or death)? So Class I or Class II recall?
From CPG Sec. 555.425; Foods, Adulteration Involving Hard or Sharp Foreign Objects:
Hard or sharp foreign objects in food may cause traumatic injury including laceration and perforation of tissues of the mouth, tongue, throat, stomach and intestine as well as damage to the teeth and gums. From 1972 through 1997, the FDA Health Hazard Evaluation Board evaluated approximately 190 cases of hard or sharp foreign objects in food. These include cases of both injury and non-injury reported to FDA. The Board found that foreign objects that are less than 7 mm, maximum dimension, rarely cause trauma or serious injury except in special risk groups such as infants, surgery patients, and the elderly. The scientific and clinical literature supports this conclusion.
