Class IITerminated · reported 2018-11-07

MUSHROOM CRIMINI SOUTHWEST STUFFED; 7oz. Black Foam Over-wrapped Trays; Keep…

Caito Foods LLC. recalled this product and the FDA reported the enforcement action on 7 November 2018 as Class II. The recall was initiated by the firm. Products recalled due to potential contamination with Listeria monocytogenes or Salmonella.

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: MUSHROOM CRIMINI SOUTHWEST STUFFED; 7oz. Black Foam Over-wrapped Trays; Keep Refrigerated; UPC 0884853631044
UPC: 0884853631044
Reason for recall: Products recalled due to potential contamination with Listeria monocytogenes or Salmonella.
Recalling firm: Caito Foods LLC.
Firm location: Indianapolis, Indiana, United States
Classification: Class II
Status: Terminated
Recall number: F-0358-2019
Quantity: 204 units
Distribution: CA, IL, IN, KY, MI, OH, PA
Initiated: 15 October 2018
Reported by FDA: 7 November 2018
Terminated: 30 November 2018
Firm notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Product codes: Mfg. Code: SN01 Item#: 11224205

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 7 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 7 separate recalls, which almost every published figure does, overstates it by a factor of 7. 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 7 of them.
The recall ran for 7 weeks, from 15 October 2018 to termination on 30 November 2018. 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 7 states, and 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.

Named in the distribution pattern: California, Illinois, Indiana, Kentucky, Michigan, Ohio, Pennsylvania. 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.

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 Caito Foods LLC.

The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 19 other records name this firm.

Reported	Product	Firm	Reason	Class
2019-05-15	Fresh cut watermelon, fresh cut honeydew melon, fresh cut cantaloupe and fresh cut mixed fruit containing one of these melons.	Caito Foods LLC.	Potential to be contaminated with Salmonella Carrau	Class I
2018-11-07	SOUTHWEST SWEET POTATO RICE; 12oz. Plastic Clamshell; Keep Refrigerated; UPC 0826766185610	Caito Foods LLC.	Products recalled due to potential contamination with Listeria monocytogenes or Salmonella.	Class II
2018-11-07	SOUTHWEST STUFFED PORTABELLA MUSHROOM; 8oz. Black Foam Over-wrapped Trays; Keep Refrigerated; UPC 0081851202676	Caito Foods LLC.	Products recalled due to potential contamination with Listeria monocytogenes or Salmonella.	Class II
2018-11-07	STREET CORN; 6oz. Plastic Clamshell; Keep Refrigerated; UPC 0884853641067	Caito Foods LLC.	Products recalled due to potential contamination with Listeria monocytogenes or Salmonella.	Class II
2018-11-07	ANCHO CHILI & CORN CAULIFLOWER RICE; 12oz. Plastic Clamshell; Keep Refrigerated; UPC 0826766185900	Caito Foods LLC.	Products recalled due to potential contamination with Listeria monocytogenes or Salmonella.	Class II
2018-11-07	SOUTHWEST CRIMINI STUFFED MUSHROOM; 7oz. Black Foam Over-wrapped Trays; Keep Refrigerated; UPC 0081851202683	Caito Foods LLC.	Products recalled due to potential contamination with Listeria monocytogenes or Salmonella.	Class II
2018-11-07	MUSHROOM PRTBELA SOUTHWEST STUFFED; 8oz. Black Foam Over-wrapped Trays; Keep Refrigerated; UPC 0884853631037	Caito Foods LLC.	Products recalled due to potential contamination with Listeria monocytogenes or Salmonella.	Class II
2018-09-12	Delish Vegetable Garden Salad, 10.5 oz. UPC 49022542426	Caito Foods LLC.	The recalling firm learned from their supplier that an ingredient distributed to them tested positive for Cyclospora.	Class II
2018-09-12	Garden Salad with Homestyle Ranch Dressing, 11.5 oz. UPC 0826766141036	Caito Foods LLC.	The recalling firm learned from their supplier that an ingredient distributed to them tested positive for Cyclospora.	Class II
2018-09-12	Vegetable Garden Salad, 8 oz. UPC 0081851223497	Caito Foods LLC.	The recalling firm learned from their supplier that an ingredient distributed to them tested positive for Cyclospora.	Class II

All 20 records for Caito Foods LLC.

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.