Class ITerminated · reported 2017-03-29

Ciao Bovina Italian Strawberry. 1 Pint (473 ml). Non-Dairy Gelato. No GMO's.

Ciao Bovina, LLC recalled this product and the FDA reported the enforcement action on 29 March 2017 as Class I. The recall was initiated by the firm. Ciao Bovina, LLC announces a voluntary field action for Italian Strawberry Gelato due to potential contamination with Hepatitis A Virus.

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
Ciao Bovina Italian Strawberry. 1 Pint (473 ml). Non-Dairy Gelato. No GMO's. Coconut Free. Soy Free.
Reason for recall
Ciao Bovina, LLC announces a voluntary field action for Italian Strawberry Gelato due to potential contamination with Hepatitis A Virus.
Recalling firm
Ciao Bovina, LLC
Firm location
Longmont, Colorado, United States
Classification
Class I
Status
Terminated
Recall number
F-1677-2017
Quantity
80 pints
Distribution
Colorado. No Canadian, other foreign, VA/govt/military consignees.
Initiated
8 October 2016
Reported by FDA
29 March 2017
Terminated
31 May 2017
Firm notified by
E-Mail
Product codes
Expiration date: 11/09/2016

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 8 months, from 8 October 2016 to termination on 31 May 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 1 state, and the FDA published the enforcement report 6 months after the firm began the recall.
  • Recalls of ice cream or frozen dessert run a median of 7 months, so this one was about typical for its category. Ice cream and frozen desserts are ready to eat and never cooked again, and freezing preserves Listeria rather than killing it, which is why a positive environmental sample in a frozen dessert plant becomes a recall rather than a corrective action.

What this recall was for

Viral and parasitic contamination

Hepatitis A, norovirus and Cyclospora recalls trace back to a person or to water rather than to the process: an infected food handler, or produce irrigated or washed with contaminated water.

A preventive controls plan covers viral or parasitic 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 117.10
Personnel: the hygiene practices, and the exclusion of anyone with an illness or open lesion that could contaminate food, that a facility must require.
21 CFR 112
Produce safety: the agricultural water, worker health and hygiene standards for farms growing produce eaten raw.
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.

Filed under ice cream and frozen desserts, milk and dairy and fresh produce. A product can sit in more than one.

Other ice cream and frozen desserts recalls for the same reason

These are the closest records in the corpus: the same kind of food, recalled for a hazard this record also names. Unlike the firm’s own records below, they come from different companies, which is what makes them a pattern rather than a history.

ReportedProductFirmReasonClass
2017-03-29Raspberry Sorbet, 5 Liter & 4 Liter pansLeo Leo GelatoLeo Leo Gelato is recalling gelato and sorbetto because they contain frozen strawberries that may be contaminated with hepatitis A virus.Class I
2017-03-29Strawberry Nutella gelato, 5 Liter & 4 Liter pansLeo Leo GelatoLeo Leo Gelato is recalling gelato and sorbetto because they contain frozen strawberries that may be contaminated with hepatitis A virus.Class I
2017-03-29Strawberry Sorbet, 5 Liter & 4 Liter pansLeo Leo GelatoLeo Leo Gelato is recalling gelato and sorbetto because they contain frozen strawberries that may be contaminated with hepatitis A virus.Class I
2017-03-29Mixed Berries gelato, 5 Liter & 4 Liter pansLeo Leo GelatoLeo Leo Gelato is recalling gelato and sorbetto because they contain frozen strawberries that may be contaminated with hepatitis A virus.Class I
2017-03-29Strawberry Cream gelato, 5 Liter & 4 Liter pansLeo Leo GelatoLeo Leo Gelato is recalling gelato and sorbetto because they contain frozen strawberries that may be contaminated with hepatitis A virus.Class I
2017-03-29Blackberry Cabernet gelato, 5 Liter & 4 Liter pansLeo Leo GelatoLeo Leo Gelato is recalling gelato and sorbetto because they contain frozen strawberries that may be contaminated with hepatitis A virus.Class I
2017-03-29Strawberry Basil gelato, 5 Liter & 4 Liter pansLeo Leo GelatoLeo Leo Gelato is recalling gelato and sorbetto because they contain frozen strawberries that may be contaminated with hepatitis A virus.Class I
2017-03-29Strawberry White Chocolate gelato, 5 Liter & 4 Liter pansLeo Leo GelatoLeo Leo Gelato is recalling gelato and sorbetto because they contain frozen strawberries that may be contaminated with hepatitis A virus.Class I

All 2017 recalls · All FDA food recall data

21 CFR 117.10 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.