5-pound cans of unpasteurized, ready-to-eat, Dungeness crab meat, packaged in reduced…
Bornstein Seafoods Inc recalled this product and the FDA reported the enforcement action on 13 February 2019 as Class I. The recall was initiated by the firm. 5-pound cans of unpasteurized, reduced oxygen packaged (ROP), ready-to-eat, Dungeness crab meat are recalled because the incorrect Time Temperature Indicator (TTI) was applied to the cans. The TTI would not indicate the temperature abuse. If the product was temperature abused, it would create the potential hazard of Clostridium botulinum growth and toxin formation.
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
- 5-pound cans of unpasteurized, ready-to-eat, Dungeness crab meat, packaged in reduced oxygen metal cans that were shipped with Fresh-Check B Time Temperature Indicator (TTIs). Product was shipped frozen. The label is read in parts: "***BORNSTEIN SEAFOODS ***WILD Dungeness CRAB MEAT***INGREDIENTS: CRAB MEAT WITH SALT ADDED ***NET WT 5 LB***HANDLING INSTRUCTIONS: To protect the delicate flavor and texture of this crab meat, we recommend the following handling practices***KEEP REFRIGERATED: 33-38 degrees F, after opening, cover remaining product during storage***PACKED BY BORNSTEIN SEAFOODS INC. ASTORIA, OR 97103***".
- Reason for recall
- 5-pound cans of unpasteurized, reduced oxygen packaged (ROP), ready-to-eat, Dungeness crab meat are recalled because the incorrect Time Temperature Indicator (TTI) was applied to the cans. The TTI would not indicate the temperature abuse. If the product was temperature abused, it would create the potential hazard of Clostridium botulinum growth and toxin formation.
- Recalling firm
- Bornstein Seafoods Inc
- Firm location
- Bellingham, Washington, United States
- Classification
- Class I
- Status
- Terminated
- Recall number
- F-0841-2019
- Quantity
- Total 1715 lbs.
- Distribution
- CA and OR
- Initiated
- 21 December 2018
- Reported by FDA
- 13 February 2019
- Terminated
- 5 July 2019
- Firm notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Product codes
- Lot A11739 and A11759. Lot #A11739 dated 11/08/18 with a stamped manufacturing code of A18312C on the can. Lot #A11759 dated 11/20/18 with a stamped manufacturing code of A18324C on the can.
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 6 months, from 21 December 2018 to termination on 5 July 2019. 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 8 weeks after the firm began the recall.
- Recalls of fish or seafood run a median of 5 months, so this one was about typical for its category. Fish and fishery products are the one food category with their own HACCP regulation in the United States, 21 CFR part 123, because the hazards are species-specific: histamine in scombroid fish, ciguatera in reef fish, and Listeria in cold-smoked products.
Named in the distribution pattern: California, Oregon. 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
Chemical contamination
A chemical contamination recall covers a substance that is harmful in food and was never meant to be there: a heavy metal, a cleaning chemical, a pesticide residue, or a natural toxin such as aflatoxin or histamine.
A preventive controls plan covers chemical 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 117.35(b)
- Substances used in cleaning and sanitizing: toxic materials stored, identified and used so they cannot contaminate food, food-contact surfaces or packaging.
- 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 117.130(b)(1)(ii)
- Hazard analysis: identifying the known or reasonably foreseeable chemical hazards, including radiological hazards, pesticide and drug residues, natural toxins and food decomposition.
Process deviation
A process deviation recall means the process ran outside its validated limits: a thermal process that did not reach its time and temperature, a pH that drifted, or a seal that failed.
A preventive controls plan covers a process deviation 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 113
- Thermally processed low-acid foods in hermetically sealed containers: the scheduled process, its establishment by a competent authority, and the records proving every container received it.
- 21 CFR 114
- Acidified foods: the controls on equilibrium pH at or below 4.6, and the process that achieves it.
- 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.
Clostridium botulinum
Clostridium botulinum recalls are recalls of the process, not of a test result: the organism produces its toxin without oxygen, so a low-acid food in a sealed container that missed its scheduled process is recalled whether or not toxin was ever found.
A preventive controls plan covers a botulism risk 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 113
- Thermally processed low-acid foods in hermetically sealed containers: the scheduled process, its establishment by a competent authority, and the records proving every container received it.
- 21 CFR 108.35
- Emergency permit control: the registration and process filing a low-acid canned food processor must hold before it may operate.
Filed under fish and seafood, meat and poultry and spices and seasonings. A product can sit in more than one.
Other fish and seafood 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.
Other records from Bornstein Seafoods Inc
The FDA opens one enforcement record per product code, so several of these are frequently one recall event.
All 3 records for Bornstein Seafoods Inc
All 2019 recalls · All FDA food recall data
21 CFR 117.35(b) 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.