Class IITerminated · reported 2018-10-31

Fire Roasted 1/2" Diced Green Zucchini ; 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
Fire Roasted 1/2" Diced Green Zucchini ; Sold in 25 lb. containers. Brand Name: Jon-Lin¿
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-0235-2019
Quantity
2,995 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: 1002205218 1002255607 1002688419 1002205218 1002255607 1002715214 1001719989 1002255607 1001719989

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.
  • The product description on this record names no food this site can classify, so it appears on no food-type page. That is a limit of the description rather than of the recall.

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.

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.

ReportedProductFirmReasonClass
2019-09-25Ore Ida Spud Bites, packaged in 5lb. plain poly foodservice bags, six bags per case, frozen, Case UPC: 1 00 72714 00093 2. SKU: OIF00093AMcCain Foods USApresence of hard foreign materialClass II
2018-10-31Fire-Roasted Home-Style Green Pepper Strips;: Sold in 20 lb. containers. Brand Name: Jon-Lin¿McCain Foods USADuring 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
2018-10-31Fire-Roasted 1/2" Diced Onions; Sold in 25 lb. containers. Brand Name:Jon-Lin¿McCain Foods USADuring 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
2018-10-31Fire Roasted 1/4" Diced Poblanos; Sold in 25 lb. containers. Brand Name: Jon-Lin¿ NatureSmart¿McCain Foods USADuring 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
2018-10-31Fire Roasted 1/2" Diced Onion/Pepper Blend; Sold in 25 lb. containers. Brand Name: Jon-Lin¿McCain Foods USADuring 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
2018-10-31Saut¿ed Green Pepper Strips: Sold in 25 lb. containers. Brand Name: Jon-Lin¿McCain Foods USADuring 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
2018-10-31Saut¿ed Organic Onion Strips; Sold in 25 lb. containers. Brand Name:Jon-Lin¿ NatureSmart¿McCain Foods USADuring 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
2018-10-31Fire-Roasted Corn & Black Bean Blend; Sold in 2 lb. containers. Brand Name: Jon-Lin¿ NatureSmart¿McCain Foods USADuring 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
2018-10-31Fire-Roasted Rubio's Fresno Chili ; Sold in 2 lb. containers. Brand Name: Chef Sensations¿McCain Foods USADuring 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
2018-10-31Fire-Roasted Bell Peppers and Onions Sold in 14 oz. package. Brand Name:Trader Joe's noneMcCain Foods USADuring 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 access

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.