Heartland Flax 14 Mesh Brown RCM Flax Certified Organic, Net WT 50 lbs.
Heartland Products, Inc. recalled this product and the FDA reported the enforcement action on 9 March 2016 as Class I. The recall was initiated by the firm. Heartland Products Inc., has initiated a recall due to potential contamination with Salmonella involving Milled Flax.
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
- Heartland Flax 14 Mesh Brown RCM Flax Certified Organic, Net WT 50 lbs. Product packaged in 50 lb Food Grade Plastic bags.
- Reason for recall
- Heartland Products Inc., has initiated a recall due to potential contamination with Salmonella involving Milled Flax.
- Recalling firm
- Heartland Products, Inc.
- Firm location
- Valley City, North Dakota, United States
- Classification
- Class I
- Status
- Terminated
- Recall number
- F-0710-2016
- Quantity
- 43,950 lbs
- Distribution
- US: ND, WA, CA, RI, SD, IL. OUS: CANADA
- Initiated
- 14 January 2016
- Reported by FDA
- 9 March 2016
- Terminated
- 18 August 2016
- Firm notified by
- Product codes
- Lot 2T330-040515-101
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 record is the only one the FDA opened for its recall event, so it covers a single product code.
- The recall ran for 7 months, from 14 January 2016 to termination on 18 August 2016. 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 4 states, and the FDA published the enforcement report 8 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.
Named in the distribution pattern: Washington, California, Rhode Island, South Dakota. 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
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 Heartland Products, Inc.
The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 6 other records name this firm.
All 7 records for Heartland Products 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.