Definitions of Recall Actions in New Zealand

1. Purpose of Recall Classification

Medsafe uses a standardized classification system to categorize recall actions for medicines and medical devices based on the level of risk to public health. https://www.medsafe.govt.nz/hot/ProductRecallInformation/ProductRecalActionDefinitions.asp This system determines the urgency of the recall, the depth of distribution from which products must be retrieved, and the communication requirements to affected parties. https://www.medsafe.govt.nz/hot/ProductRecallInformation/ProductRecalActionDefinitions.asp

2. Recall Classes (Risk Levels)

Recalls are classified into three classes according to the potential health hazard:

Class I Recall

A situation where there is a reasonable probability that the use of or exposure to the product will cause serious adverse health consequences or death. https://www.medsafe.govt.nz/hot/ProductRecallInformation/ProductRecalActionDefinitions.asp

Examples include products contaminated with pathogenic microorganisms, incorrect active ingredient, or labelling errors that could lead to serious harm.

Class II Recall

A situation where use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. https://www.medsafe.govt.nz/hot/ProductRecallInformation/ProductRecalActionDefinitions.asp

Examples include sub-potent products, minor labelling errors, or devices with non-critical malfunctions.

Class III Recall

A situation where use of or exposure to the product is not likely to cause adverse health consequences, but the product is in violation of regulatory requirements (e.g., good manufacturing practice) or is defective in some other way. https://www.medsafe.govt.nz/hot/ProductRecallInformation/ProductRecalActionDefinitions.asp

Examples include minor packaging defects or products that do not meet specifications but pose no significant risk.

3. Recall Levels (Depth of Recall)

The level determines how far back in the distribution chain the recall must extend:

Consumer Level

Recall reaches all the way to the end user/consumer/patient. https://www.medsafe.govt.nz/hot/ProductRecallInformation/ProductRecalActionDefinitions.asp

Used for Class I recalls or when direct patient safety is at immediate risk.

Retail Level

Recall to the retail/wholesale level (e.g., pharmacies, hospitals, clinics); product may remain with patients already in possession. https://www.medsafe.govt.nz/hot/ProductRecallInformation/ProductRecalActionDefinitions.asp

Common for Class II recalls where risk is lower.

Trade Level

Recall only to wholesalers/distributors; product remains in retail and consumer channels. https://www.medsafe.govt.nz/hot/ProductRecallInformation/ProductRecalActionDefinitions.asp

Used for Class III recalls or very low-risk situations.

4. Additional Considerations

• Urgency — Class I recalls require immediate action (often within 24–48 hours); Class II and III have longer timelines.
• Communication — Sponsors must notify affected parties promptly using appropriate channels (e.g., direct letters for consumer level, trade notices for trade level).
• Field Safety Corrective Actions (FSCAs) — For devices, actions such as software updates or additional instructions may be classified similarly but might not always require full product return.
• Voluntary Nature — Most recalls in New Zealand are initiated voluntarily by sponsors following the Uniform Recall Procedure. https://www.medsafe.govt.nz/hot/ProductRecallInformation/ProductRecalActionDefinitions.asp

5. Application to Medicines and Devices

These definitions apply uniformly to both medicines and medical devices, though the specific triggers and actions may differ slightly due to regulatory differences. https://www.medsafe.govt.nz/hot/ProductRecallInformation/ProductRecalActionDefinitions.asp

Understanding these classifications helps stakeholders interpret recall notices and implement appropriate responses to protect patient safety. https://www.medsafe.govt.nz/hot/ProductRecallInformation/ProductRecalActionDefinitions.asp