Class ITerminated · reported 2012-10-17

Harris Teeter, Stuffed Flounder 8ct (Fresh).

3fish Inc. recalled this product and the FDA reported the enforcement action on 17 October 2012 as Class I. The recall was initiated by the firm. Products were manufactured with diced onions that were recalled due to Listeria monocytogenes contamination.

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: Harris Teeter, Stuffed Flounder 8ct (Fresh).
Reason for recall: Products were manufactured with diced onions that were recalled due to Listeria monocytogenes contamination.
Recalling firm: 3fish Inc.
Firm location: Gastonia, North Carolina, United States
Classification: Class I
Status: Terminated
Recall number: F-0047-2013
Quantity: 196 lbs (8ct/lb)
Distribution: NC and SC
Initiated: 7 September 2012
Reported by FDA: 17 October 2012
Terminated: 11 February 2014
Firm notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Product codes: Item #79204, Lot #22YAW1A1235 (Diced Yellow Onions)

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 12 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 12 separate recalls, which almost every published figure does, overstates it by a factor of 12. 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 12 of them.
The recall ran for 17 months, from 7 September 2012 to termination on 11 February 2014. 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 6 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: North Carolina, South Carolina. 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.

Other records from 3fish Inc.

The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 11 other records name this firm.

Reported	Product	Firm	Reason	Class
2012-10-17	Harris Teeter, Stuffed Tilapia 8ct (Fresh)	3fish Inc.	Products were manufactured with diced onions that were recalled due to Listeria monocytogenes contamination.	Class I
2012-10-17	HT Signature Lump Crab Cake (Fresh), #81791, 4 oz @ 2x8ct, Net wt. 4 lbs, Packed by 3fish, Inc.	3fish Inc.	Products were manufactured with diced onions that were recalled due to Listeria monocytogenes contamination.	Class I
2012-10-17	HT Premium Lobster Cake (fresh), 3 oz @ 2x8ct, Net Wt: 3 lbs, Packed by 3fish, Inc.	3fish Inc.	Products were manufactured with diced onions that were recalled due to Listeria monocytogenes contamination.	Class I
2012-10-17	Harris Teeter, Atlantic Stuffed Salmon 8ct (Fresh)	3fish Inc.	Products were manufactured with diced onions that were recalled due to Listeria monocytogenes contamination.	Class I
2012-10-17	MD Crab Cakes - Value Tray Pack (Frozen), 6 4x3oz, Customer Item: 504583, Packed by 3fish, Inc.	3fish Inc.	Products were manufactured with diced onions that were recalled due to Listeria monocytogenes contamination.	Class I
2012-10-17	Frozen Crab Bites, ¿ oz, Bulk 100 x 0.5oz, Net Wt: 50 oz, Packed by 3fish, Inc.	3fish Inc.	Products were manufactured with diced onions that were recalled due to Listeria monocytogenes contamination.	Class I
2012-10-17	Crab Stuffing Bucket (fresh and frozen), #84480, 5 lb Tub, Net St: 5 lbs, Packed by 3fish, Inc.	3fish Inc.	Products were manufactured with diced onions that were recalled due to Listeria monocytogenes contamination.	Class I
2012-10-17	Charl Crab Cake Bulk (fresh), #81873, 2x8ct, 4 oz, Net Wt. 4 lbs, Packed by 3fish, Inc.	3fish Inc.	Products were manufactured with diced onions that were recalled due to Listeria monocytogenes contamination.	Class I
2012-10-17	Maryland Crab Cake Bulk (fresh), #81868, 4oz @2x8ct, Net Wt. 4 lbs, Packed by 3fish, Inc.	3fish Inc.	Products were manufactured with diced onions that were recalled due to Listeria monocytogenes contamination.	Class I
2012-10-17	Carolina Style Crab Cakes (Frozen), 2 x 8ct INGLES, Net Wt 4 lbs, Packed by 3fish, Inc.	3fish Inc.	Products were manufactured with diced onions that were recalled due to Listeria monocytogenes contamination.	Class I

All 12 records for 3fish Inc.

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 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.