Go to Step 1 in the recall procedure for immediate and significant threats; radiopharmaceuticals; biologicals, human blood and blood components.

This information will help sponsors in Step 4 of the recall procedure to decide whether to undertake:

1. a recall and, if so, the type, class and level of recall

OR

2. a non-recall action, if you decide to not undertake a recall.

It is important that the TGA agrees to the type, class and level of recall action (go to Step 8).

On this page: Types of recall action | Classes of recalls | Levels of recalls | Non-recall actions

Types of recall action

Read through the types of recalls. Use your risk analysis and all the information you have to determine which of the following four types of recall actions applies to your situation:

• Recall
• Product defect correction
• Hazard alert (implanted medical devices and biologicals)
• Product defect alert

Recall

A recall is one type of recall action.

A recall is conducted to remove therapeutic goods permanently from the market or from use when there are deficiencies or potential deficiencies in safety, quality, efficacy, performance or presentation.

Recall includes:

• Removal from supply or use of products with inherent design or manufacturing defects
• Requests to check and return products found to be defective sent to:
  • pharmacists
  • hospitals
  • pathology laboratories
  • fractionators
  • operating and research facilities
  • biomedical engineers
  • others.

Recall does not include:

• removal of time-expired products where those products were released prior to their expiry. NB: product released after its expiry is considered a process failure in which case the URPTG should be applied.
• removal of appropriate numbers of products for testing to determine whether there are deficiencies relating to quality, safety, efficacy, performance or presentation.

Product defect correction

A product defect correction is undertaken to correct a specific or potential deficiency.

In some instances, the product can continue to be used if there is robust mitigation in place until a permanent correction has been implemented.

Product defect correction includes:

• the repair, modification, adjustment or re-labelling of therapeutic goods for reasons relating to deficiencies in the quality, safety, efficacy, performance or presentation
• corrections involving a product's expiry date
• updates or changes to any accessories, operating instructions or software.
  • This includes updates to Service Manuals and preventative maintenance procedures where the sponsor does not directly undertake service activities e.g. if hospital biomedical engineering staff perform the servicing.

The corrective action may take place at any agreed location, including:

• the user's premises (field correction)
• any other agreed location.

Product defect correction does not include removal of individual products for:

• repair in the event of an incidental malfunction or failure as a result of normal wear and tear or lack of good maintenance
• appropriate preventative maintenance
• modification due to technical improvements (that does not relate to quality, safety, efficacy, performance or presentation).

Hazard alert (implanted medical devices and biologicals)

A hazard alert is issued for an implanted therapeutic good with a deficiency or potential deficiency relating to its safety, quality, performance or efficacy because implanted goods (medical devices or biologicals) cannot be recalled.

Hazard alerts consist of:

• precautionary information for health professionals, including advice on:
  • situations to be aware of
  • potential complications
• advice about on-going management of affected patients.

A hazard alert may be issued in conjunction with a recall notice for affected products that have not been implanted.

Product defect alert

Discontinuation of treatment is sometimes riskier than continued use of the deficient product. This occurs for critical therapeutic goods for which there is no alternative product or for which a recall action will result in interruption of patient treatment or a medicine shortage.

Product defect alerts:

• raise awareness of the concerns about safety, quality, efficacy or performance
• describe actions that clinicians or patients may take to mitigate risks due to product deficiencies.

A product defect alert may later be followed by a recall once unaffected or alternative products become available.

Classes of recalls

Follow this guide to determine the class of recall.

There are three risk classes to convey the seriousness of the issue and degree of risk involved.

• Class I - Most serious safety-related
• Class II - Urgent safety-related
• Class III - Lowest risk

Class I - Most serious safety-related

A situation in which there is a reasonable probability that the use of, or exposure to, the deficient therapeutic good(s) will cause serious adverse health consequences or death.

Class I examples

Medicines (with serious medical consequences)

• Wrong medicine (label and contents are different)
• Chemical contamination
• Microbial contamination of sterile injectable or ophthalmic medicine
• Mix-up of some medicines ('rogues') with more than one container involved
• Wrong active ingredient in a multi-component medicine

Medical devices

• Hot/cold gel pack contains a toxic substance that could be ingested accidentally by a child
• Higher fracture rates for implantable cardiac leads that may result in Implantable Cardioverter Defibrillators (ICDs) not providing effective therapy, resulting in serious injury or death
• Software defects resulting in linear accelerators delivering the wrong radiation dose or delivering doses to the wrong location
• Hardware or software failures in ventilators resulting in shut down during its use
• A false result on an IVD test for a medicine with a narrow therapeutic range that could lead to an overdose, causing permanent injury
• A false negative result on an IVD test for a serious or highly contagious disease

Biologicals and blood components

• Retained samples of pulmonary allograft showing positive microbial growth of a pathogenic organism
• Blood components accidently released after donation testing initial-positive to mandatory testing

Class II - Urgent safety-related

A situation in which use of, or exposure to, the deficient therapeutic good(s) may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Class II examples

Medicines

When there are medical consequences:

• Mislabelling (e.g. wrong or missing text or figures)
• Missing or incorrect safety information in leaflets or inserts
• Microbial contamination of non-injectable, non-ophthalmic sterile medicine
• Mix-up of medicines in containers ('rogues')
• Non-compliance with specifications, such as in an assay, stability, fill or weight
• Insecure or incorrect closures for medicines such as cytotoxics, potent goods and medicines requiring child-resistant packaging

Medical devices

• Microbial contamination of a personal lubricant
• Higher than expected rate of revision surgeries due to mechanical failures to one of the components in a total hip, knee or shoulder implant
• Infusion pumps giving visual or audible alarms due to software or hardware issues resulting in delay in infusion
• Omission of precautionary information on procedures that could cause complications for the patient, such as omission from the Instructions for Use for a catheter of a precaution for certain procedures that could cause complications in its removal
• An IVD test kit that could identify the wrong strain of micro-organism and lead to inappropriate treatment

Biologicals and blood components

• Subsequent testing of the bone donor has shown development of cancer
• The culture sample for microbial testing was mislabelled with that of another donor, resulting in the potential for the biological being released with untraceable results
• Suspected bacterial contamination due to adverse transfusion reaction while infusing the blood component manufactured from the same donation
• Geographical or medication deferral not applied or applied incorrectly for the blood donation

Class III - Lowest risk

A situation in which use of, or exposure to, the deficient therapeutic good(s) is not likely to cause adverse health consequences.

Class III examples

The goods meet acceptable standards of safety and efficacy and the issue does not in itself present an imminent risk.

However, if not rectified, the situation may present a hazard in the future.

Medicines

• Faulty packaging, such as wrong or missing batch number or expiry date
• Faulty container closure
• Contamination including:
  • microbial spoilage
  • dirt or detritus
  • particulate matter

Medical devices

• The outer packaging of a medical device indicates a different size to the one supplied in the box, but it would be obvious to the clinician that the device was the incorrect size
• An IVD reagent is causing calibration failures towards the end of its shelf life, but there is no effect on patient results

Disinfectants

• A disinfectant has been mislabelled with an expiry date that predates the actual expiry date

Levels of recalls

The action level (or depth) describes who will be notified of the recall action.

Determining the level

To determine the level consider the following:

• channels by which the product has been distributed
• extent of the distribution
• potential risks to a user because of the issue
• likelihood of the issue with the goods occurring
• ability of the consumer, health professional or caregiver to identify the issue
• whether the good is outside the manufacturer's specifications
• availability of a replacement or alternative good, or the risk associated with not providing treatment if a replacement or alternative good is not available
• whether a recall (if a medicine) will cause a medicine shortage.

There are four levels for a recall:

• Wholesale level
• Hospital level
• Retail level
• Consumer level

Wholesale level

Includes:

• medicine and medical device wholesalers, who are third parties holding goods to distribute to retailers or other organisations
• State and Territory purchasing authorities.

Hospital level

Includes:

• wholesale level
• hospitals
• nursing homes, hostels and other healthcare institutions
• clinical investigators and the institutions in which clinical investigations are performed
• hospital pharmacies, blood banks, pathology laboratories, operating facilities, fractionators, human tissue banks, other hospital departments
• ambulance services including the Royal Flying Doctor Service.

Retail level

Includes:

• hospital and wholesale levels
• retail pharmacists
• dentists
• health care professionals
• all other retail outlets such as supermarkets, health food stores and online stores.

Consumer level

Includes:

• retail, hospital and wholesale levels
• patients and other consumers.

Non-recall actions

Not all issues require recall actions. You can conduct a non-recall action if:

• the therapeutic goods meet all specifications and standards

AND

• there are no deficiencies in safety, quality, efficacy, performance or presentation.

Make sure that we agree that a non-recall action is appropriate.

There are four types of non-recall actions:

• Safety alert
• Product notification
• Quarantine
• Product withdrawal

Safety alert

Safety alerts are issued to provide information on the safe use of therapeutic goods in certain situations where, although meeting all specifications and therapeutic indications, its use could present an unreasonable risk of harm if certain specified precautions are not followed.

A safety alert is generally used for reiterating specific precautions or instructions regarding use of the goods.

We review the final signed safety alert (Step 8 of the recall procedure) and will:

• contact you with the outcome of our review
• distribute the safety alert to:
  • state and territory recall coordinators
  • relevant parties listed in the Australian Recall Coordinator recall notification list.

Product notification

A product notification provides information about a therapeutic good in a situation that is unlikely to involve significant adverse health consequences.

Quarantine

Consideration should be given to initiating a quarantine of goods if a defect is identified in released goods which has the potential to raise issues related to safety, efficacy (medicines / biologicals) or performance (medical devices).

A quarantine action suspends further supply and distribution of the goods pending your investigation of an issue or incident. The outcome of the investigation will determine further actions.

Any given recall or non-recall action may occur after your quarantine notice is agreed. Distribution of your quarantine notice needs to be commensurate with the depth of supply of the goods, to either the wholesale, hospital or retail level. We review the final signed quarantine notice (Step 8 of the recall procedure) and will:

• contact you with the outcome of our review
• distribute the quarantine notice to:
  • state and territory recall coordinators
  • relevant parties listed in the Australian Recall Coordinator recall notification list; and
• any other body as deemed necessary given the nature of the matters at hand e.g. professional bodies.

When you advise us the outcome of the investigation, we will determine whether the quarantine can be lifted or whether further recall action is required (if recall action is required, return to Step 2 of the recall procedure).

If the quarantine can be lifted, we will review your second notice advising of this action (Step 8 of the recall procedure) and will:

• contact you with the outcome of our review
• distribute the second notice to:
  • state and territory recall coordinators
  • relevant parties listed in the Australian Recall Coordinator recall notification list; and
• any other body who received the original notice.

Product withdrawal

A product withdrawal is used to withdraw products for reasons that are not related to safety, quality, efficacy, performance or presentation, e.g. removing a previous model from the market when a new model has been released.