Saut¿ed 3/8" Diced Organic Onions; Sold in 25 lb. containers. Brand Name: Jon-Lin¿…
McCain Foods USA recalled this product and the FDA reported the enforcement action on 31 October 2018 as Class II. The recall was initiated by the firm. During an internal audit at the manufacturing location, it was discovered that finished product had been released on numerous occasions after receiving presumptive positive test results for Listeria monocytogenes and Salmonella; confirmation was not conducted.
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
- Saut¿ed 3/8" Diced Organic Onions; Sold in 25 lb. containers. Brand Name: Jon-Lin¿ NatureSmart¿
- Reason for recall
- During an internal audit at the manufacturing location, it was discovered that finished product had been released on numerous occasions after receiving presumptive positive test results for Listeria monocytogenes and Salmonella; confirmation was not conducted.
- Recalling firm
- McCain Foods USA
- Firm location
- Oakbrook Ter, Illinois, United States
- Classification
- Class II
- Status
- Terminated
- Recall number
- F-0234-2019
- Quantity
- 9668 cases
- Distribution
- US and Canada, China, Korea and Mexico
- Initiated
- 13 October 2018
- Reported by FDA
- 31 October 2018
- Terminated
- 1 November 2019
- Firm notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Product codes
- All products shipped on or after January 1, 2016 Batch numbers: 1002200050 1002201565 1002239185 1002325300 1002330858 1002332312 1002778707 1002801550 1002812013 1001567768 1001592433 1001593991 1001624384
Reading this record
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 63 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 63 separate recalls, which almost every published figure does, overstates it by a factor of 63. 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 63 of them.
- The recall ran for 13 months, from 13 October 2018 to termination on 1 November 2019. 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 FDA published the enforcement report 3 weeks after the firm began the recall.
- Recalls of fresh produce run a median of 7 months, so this one was longer 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.
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.
Salmonella
Salmonella is a bacterium that survives in low-moisture foods for months, which is why it appears in recalls of products that carry no water for it to grow in: nut butters, spices, flour and dry pet food.
A preventive controls plan covers Salmonella 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)(1)
- Process controls: the controls that apply a treatment, such as a validated kill step, at the point where it reduces the hazard to a safe level.
- 21 CFR 117 subpart G
- Supply-chain programme: the approval and verification a receiving facility runs on a supplier when the hazard is controlled before the ingredient arrives.
- 21 CFR 117.165(a)(2)
- Product testing: testing as a verification activity, appropriate to the facility, the food and the nature of the preventive control.
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 McCain Foods USA
The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 71 other records name this firm.
| Reported | Product | Firm | Reason | Class |
|---|---|---|---|---|
| 2019-09-25 | Ore Ida Spud Bites, packaged in 5lb. plain poly foodservice bags, six bags per case, frozen, Case UPC: 1 00 72714 00093 2. SKU: OIF00093A | McCain Foods USA | presence of hard foreign material | Class II |
| 2018-10-31 | Fire-Roasted Home-Style Green Pepper Strips;: Sold in 20 lb. containers. Brand Name: Jon-Lin¿ | McCain Foods USA | During an internal audit at the manufacturing location, it was discovered that finished product had been released on numerous occasions after receiving presumptive positive test results for Listeria monocytogenes and Salmonella; confirmation was not conducted. | Class II |
| 2018-10-31 | Fire-Roasted 1/2" Diced Onions; Sold in 25 lb. containers. Brand Name:Jon-Lin¿ | McCain Foods USA | During an internal audit at the manufacturing location, it was discovered that finished product had been released on numerous occasions after receiving presumptive positive test results for Listeria monocytogenes and Salmonella; confirmation was not conducted. | Class II |
| 2018-10-31 | Fire Roasted 1/4" Diced Poblanos; Sold in 25 lb. containers. Brand Name: Jon-Lin¿ NatureSmart¿ | McCain Foods USA | During an internal audit at the manufacturing location, it was discovered that finished product had been released on numerous occasions after receiving presumptive positive test results for Listeria monocytogenes and Salmonella; confirmation was not conducted. | Class II |
| 2018-10-31 | Fire Roasted 1/2" Diced Onion/Pepper Blend; Sold in 25 lb. containers. Brand Name: Jon-Lin¿ | McCain Foods USA | During an internal audit at the manufacturing location, it was discovered that finished product had been released on numerous occasions after receiving presumptive positive test results for Listeria monocytogenes and Salmonella; confirmation was not conducted. | Class II |
| 2018-10-31 | Saut¿ed Green Pepper Strips: Sold in 25 lb. containers. Brand Name: Jon-Lin¿ | McCain Foods USA | During an internal audit at the manufacturing location, it was discovered that finished product had been released on numerous occasions after receiving presumptive positive test results for Listeria monocytogenes and Salmonella; confirmation was not conducted. | Class II |
| 2018-10-31 | Saut¿ed Organic Onion Strips; Sold in 25 lb. containers. Brand Name:Jon-Lin¿ NatureSmart¿ | McCain Foods USA | During an internal audit at the manufacturing location, it was discovered that finished product had been released on numerous occasions after receiving presumptive positive test results for Listeria monocytogenes and Salmonella; confirmation was not conducted. | Class II |
| 2018-10-31 | Fire-Roasted Corn & Black Bean Blend; Sold in 2 lb. containers. Brand Name: Jon-Lin¿ NatureSmart¿ | McCain Foods USA | During an internal audit at the manufacturing location, it was discovered that finished product had been released on numerous occasions after receiving presumptive positive test results for Listeria monocytogenes and Salmonella; confirmation was not conducted. | Class II |
| 2018-10-31 | Fire-Roasted Rubio's Fresno Chili ; Sold in 2 lb. containers. Brand Name: Chef Sensations¿ | McCain Foods USA | During an internal audit at the manufacturing location, it was discovered that finished product had been released on numerous occasions after receiving presumptive positive test results for Listeria monocytogenes and Salmonella; confirmation was not conducted. | Class II |
| 2018-10-31 | Fire-Roasted Bell Peppers and Onions Sold in 14 oz. package. Brand Name:Trader Joe's none | McCain Foods USA | During an internal audit at the manufacturing location, it was discovered that finished product had been released on numerous occasions after receiving presumptive positive test results for Listeria monocytogenes and Salmonella; confirmation was not conducted. | Class II |
All 72 records for McCain Foods USA
All 2018 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.