10209, Roman Meal New 12 Grain Mix (wheat bran, sunflower, wheat germ, wheat, barley…
Dakota Specialty Milling, Inc recalled this product and the FDA reported the enforcement action on 20 March 2013 as Class II. The recall was initiated by the firm. Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.
The record
Every field below is published by the FDA in the openFDA food enforcement database. Check the FDA notice before acting on any recall: this page is a reading of the public record, not a substitute for it.
Product
10209, Roman Meal New 12 Grain Mix (wheat bran, sunflower, wheat germ, wheat, barley, sesame seed, Millet, yellow corn, brown flax, Triticale, Oats, Rye, buckwheat, spelt, Brown Rice, kamut flour, amaranth flour), Roman Meal Company, Tacoma, Washington, 1 Net WT 50 LBS.
Reason for recall
Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.
Five things about this record are not in the record itself, and each one changes how it should be read.
Class II means the FDA judged a remote probability of serious harm, or a probability of temporary or medically reversible harm. The class is assigned by an agency health hazard evaluation under 21 CFR 7.41, not by the firm.
The firm started this recall itself. Most FDA food recalls are voluntary, and a recall is a food safety plan working rather than failing. The circumstances in which the agency asks for one instead are set out in 21 CFR 7.45.
This is one of 52 records covering the same recall event. The FDA opens one enforcement record per product code, so a recall of a product line appears here many times. Counting these records as 52 separate recalls, which almost every published figure does, overstates it by a factor of 52. Every product code in this event is listed together on the record that covers the whole recall, which is the page a search engine is pointed to for all 52 of them.
The recall ran for 11 months, from 14 February 2013 to termination on 10 January 2014. Termination means the agency judged that all reasonable effort had been made, under 21 CFR 7.55, and it says nothing about whether product remained in circulation.
The distribution pattern names 21 states, and the FDA published the enforcement report 5 weeks after the firm began the recall.
Recalls of nuts or seeds run a median of 7 months, so this one was longer than usual for its category. Nuts and seeds carry both hazards at once: they are a major allergen in their own right, and as a low-moisture food they hold Salmonella for months without supporting its growth, which is why a nut butter recall can trace to a lot pressed a year earlier.
A foreign material recall means something that is not food was found in food: metal, plastic, glass, wood or insect matter, usually shed by equipment during processing.
A preventive controls plan covers foreign material under the clauses below. This is where the control belongs, not a finding against any firm named on this page: a recall record states a reason, and most of these recalls were initiated by the firm itself.
21 CFR 117.40
Equipment and utensils: plant equipment designed and maintained so it cannot contaminate food with lubricants, fuel, metal fragments or contaminated water.
21 CFR 117.80(c)
Manufacturing operations: the measures that protect food from contamination during processing, including the effective ones against metal and other extraneous material.
21 CFR 117.150
Corrective actions: what a facility does when a preventive control was not properly implemented, including identifying and correcting the problem and evaluating the food for safety.
These are the closest records in the corpus: the same kind of food, recalled for a hazard this record also names. Unlike the firm’s own records below, they come from different companies, which is what makes them a pattern rather than a history.
Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.
Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.
Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.
Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.
Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.
Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.
Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.
Some flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.
21 CFR 117.40 is the clause behind this recall, and it is one somebody has to produce evidence for at their next audit. Krolda maps supplier documents to the clause they satisfy in FSSC 22000, IFS Food and 21 CFR 117, and routes the corrective action when the evidence is missing.
Recall records come from the openFDA food enforcement API, published by the U.S. Food and Drug Administration in the public domain. Krolda adds the hazard classification and the clause mapping; neither is an FDA determination. Always check the FDA notice before acting on a recall.
