FE Rainbow Blend, Product Code 22795. 50 lb corrugated case with polyliner.
QualiTech, Inc recalled this product and the FDA reported the enforcement action on 26 October 2016 as Class I. The recall was initiated by the firm. QualiTech has been notified by a supplier that they received material with the potential presence of E. coli O121 bacteria.
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
- FE Rainbow Blend, Product Code 22795. 50 lb corrugated case with polyliner. Manufactured by: QualiTech, 318 Hazeltine Drive, Chaska, MN 55318 USA
- Reason for recall
- QualiTech has been notified by a supplier that they received material with the potential presence of E. coli O121 bacteria.
- Recalling firm
- QualiTech, Inc
- Firm location
- Chaska, Minnesota, United States
- Classification
- Class I
- Status
- Terminated
- Recall number
- F-0205-2017
- Quantity
- 1,400 lbs.
- Distribution
- AZ, CA, GA, ID, IL, IN, MI, MN, TX, WA. Outside the US to include: Canada.
- Initiated
- 5 July 2016
- Reported by FDA
- 26 October 2016
- Terminated
- 13 September 2017
- Firm notified by
- Product codes
- Lot: 31950
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 18 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 18 separate recalls, which almost every published figure does, overstates it by a factor of 18. 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 18 of them.
- The recall ran for 14 months, from 5 July 2016 to termination on 13 September 2017. 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 9 states, and the FDA published the enforcement report 4 months 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.
Named in the distribution pattern: Arizona, California, Georgia, Idaho, Illinois, Indiana, Michigan, Minnesota, Texas. 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
E. coli
Shiga toxin-producing E. coli recalls concentrate in foods eaten raw or lightly cooked, where no step in the process is hot enough or long enough to be a kill step.
A preventive controls plan covers E. coli 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 120
- Juice HACCP: the hazard analysis and critical control point system required for juice processors, including a treatment achieving a 5-log pathogen reduction.
Other records from QualiTech, Inc
The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 17 other records name this firm.
All 18 records for QualiTech, Inc
All 2016 recalls · All FDA food recall data
21 CFR 117.135(c)(1) 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.