Yellow onions Diced 3/8", packaged in 25-lb. plastic bags, 1 per case (item 19551)…
Cool Creations, LLC recalled this product and the FDA reported the enforcement action on 29 August 2012 as Class I. The recall was initiated by the firm. Products may be contaminated with Listeria monocytogenes
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
- Yellow onions Diced 3/8", packaged in 25-lb. plastic bags, 1 per case (item 19551); Diced 1/4", packaged in 5-lb. bags, 2 per case (item #19516), 4 per case (item 19510), and 1 per case (item 19515). Diced yellow onion packaged in 5-oz. plastic containers, 4 per case, UPC 815970010153, and 10-oz. plastic containers, 4 per case, UPC 815970011082, for retail sale. The firm name on the label is Cool Creations, LLC, North Kansas City, MO.
- UPC
- 815970010153
- Reason for recall
- Products may be contaminated with Listeria monocytogenes
- Recalling firm
- Cool Creations, LLC
- Firm location
- North Kansas City, Missouri, United States
- Classification
- Class I
- Status
- Terminated
- Recall number
- F-1995-2012
- Quantity
- N/A
- Distribution
- Direct distribution was made to KS, MO, and OK.
- Initiated
- 26 July 2012
- Reported by FDA
- 29 August 2012
- Terminated
- 4 October 2012
- Firm notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Product codes
- Lot numbers 12201 thru 12207 (last use by date affected is 8/30/2012)
Reading this record
Five things about this record are not in the record itself, and each one changes how it should be read.
- Class I means the FDA judged a reasonable probability that the product would cause serious health consequences or death. 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 19 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 19 separate recalls, which almost every published figure does, overstates it by a factor of 19. 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 19 of them.
- The recall ran for 2 months, from 26 July 2012 to termination on 4 October 2012. 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 2 states, and the FDA published the enforcement report 5 weeks after the firm began the recall.
- Recalls of fresh produce run a median of 7 months, so this one was shorter than usual for its category. Fresh produce is the category where contamination arrives before the facility does: irrigation water, soil amendments and field workers are the routes, and nothing downstream of the farm is a kill step for a product eaten raw.
Named in the distribution pattern: Missouri, Oklahoma. Those pages count recalls by where the RECALLING FIRM sits, which is a different question from where this product went.
What this recall was for
Listeria monocytogenes
Listeria monocytogenes is a bacterium that grows at refrigeration temperature, which is why it dominates recalls of ready-to-eat foods that are never cooked again before they are eaten.
A preventive controls plan covers Listeria contamination 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 117.135(c)(3)
- Sanitation controls: the controls on cleaning food-contact surfaces and on preventing cross-contact and cross-contamination from insanitary objects, people and equipment.
- 21 CFR 117.165(a)(3)
- Environmental monitoring: testing the processing environment for an environmental pathogen, required when a ready-to-eat food is exposed to the environment before packaging.
- 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.
Filed under fresh produce. A product can sit in more than one.
Other fresh produce recalls for the same reason
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.
Other records from Cool Creations, LLC
The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 18 other records name this firm.
All 19 records for Cool Creations, LLC
All 2012 recalls · All FDA food recall data
21 CFR 117.135(c)(3) 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.
Early accessRecall 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.