Product Recalls: Before, During and After

Cynthia A. Boeh, VP & GCMiSUMi USA, Inc.

Why?• Safety• Reputation • Finances

Who should learn about recalls?• Every in-house attorney • Recalls have no boundaries and cross

all industries – drugs, cars, machines, food, consumer products…..

Recent RecallsTakata – air bags exploding and shooting shrapnel in over 10.5 million vehiclesTeavana – glass pitchers pose laceration or burn hazardFrozen Yellow-Fin Tuna – salmonella contaminationCost Plus World Market – bistro chair legs may unexpectedly bendDuPont – 1000’s of trees killed by Imprelis herbicide, up to $19K a tree, plus cost to remove dead trees ++

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3 Phases of Recall 1. Prepare

2. Investigate, analyze and determine action

3. Recover, regroup

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Prepare…prepare…prepare• Create (and continually update) recall / crises plan• Ensure buy in from the top• Train employees• Governing agency/agencies – establish relationships

– FDA, FAA, OSHA, CPSC, EPA, European Commission• Appoint an executive to be spokesperson • Appoint point person in charge of daily activities in case of recall• Assign a team• Conduct a mock emergency

Analyze Situation• How serious is the situation?• Death, injury, property damage• How widespread is the problem?• # of products involved• How big of geographic area?• Did we know about it ahead of time? INVESTIGATE• Did we do enough at the time the first claims started coming in?• When does the board need to be notified?• Can products be found/traced to users?• Re-evaluate as more information is gathered• Get field team together

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Regulatory• Regulatory obligation to report?– CPSC has very regimented requirementsSee 16 CFR 1115.13 et sec and www.cpsc.gov- Medical Devices – FDA - 21 CFR 803- Motor Vehicle Industry related – NHTSA - 49 CFR

Parts 573, 574, 576, 579 • Report voluntarily?

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Recall Guidance

• Regulatory agencies provide guidance– CPSC: Consumer Product Safety Commission

http://www.cpsc.gov/en/Business--Manufacturing/Recall-Guidance/– FDA: Federal Drug Administration http://

www.fda.gov/Safety/Recalls/IndustryGuidance/ucm129334.htm http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm049070.htm

– ISO: International Organization for Standardization 10393:2013

– OECD: Organisation for Economic Co-operation and Development http://globalrecalls.oecd.org/

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Corrective Action• Warning• Fix on fail• Recall– What is product population?– Need product to be returned?– If only a part of entire product, provide

replacement part for self fix? Require 3rd party?– PR messaging important

Steps of a RecallNotice: to regulatory bodies, distributors, consumers, etc.Recovering the product:

Tracing product: serial number, bar code, batch numbersTracing the owners: sales records, warranty cards, distributor sales,

GPSHow product to be returned/tracked: prepaid shipping?

Replacing the product or providing refund: may provide owner with option(s)Reintroduction of product? How?Reward key individuals who made the recall a successAudit the recall – revise plan by including what went well and learning how to rectify the things that went wrong

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Top 10 Tips to Remember1. Be prepared2. NEVER lie3. Take charge of message immediately (media strategy)4. Have a delegated team (include experts?)5. Have one spokesperson (Senior Executive)6. Decide if a corrective action/recall is necessary7. Keep employees in the loop (suppliers/distributors)8. Encourage reporting of potential pitfalls, mistakes9. Own up to fault & do the right thing10. Discuss and implement lessons learned

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Other issues to consider…

• Recall insurance?• Bringing in others (ex. suppliers, manufacturers of

components)• Dealing with insurance• When/if to bring back product in question

Thank you.

Cynthia Adamson BoehVice President and General CounselMisumi USA