Sub menu

 
 

System for Australian Recall Actions (SARA): about the search results

Last updated

There are two types of results:

Search result summary

This report shows a list of recall actions listed in a table format ordered from most recent 'Recall action commencement date' to the oldest.

  • All columns except 'Product name/description' can be sorted in ascending or descending order.
  • The product names in the 'Product name/description' column are hyperlinks which can be selected to view the detailed notification about that recall action.
Headings and definitions
Column heading Definition
Recall action commencement date The date the recall action strategy and communication was agreed by the TGA.
Product name/description Brand name/trade name (including active ingredient for medicines), and may include generic reference for the kind of medical devices. Includes all necessary information such as affected catalogue / model and / or batch / serial numbers.
Type of product Medicine (including vaccines), medical device or biological.

Medicine - Medicines are therapeutic goods (other than biologicals) that are represented to achieve, or are likely to achieve, their principal intended action by pharmacological, chemical, immunological or metabolic means in or on the body of a human

Medical Device - Medical devices include a wide range of products, such as medical gloves, bandages, syringes, blood pressure monitors and X-ray equipment. They generally have a physical or mechanical effect on the body, or are used to measure (or monitor) the body and its functions.

Biological - A good that comprises, contains, or is derived from human cells or tissues; or comprises or contains live animal cells, tissues or organs; and is represented in any way to be, or is likely to be, for therapeutic use.
Recall action**

A recall action is an action taken to resolve a problem with a therapeutic good already supplied in the market for which there are issues or deficiencies in relation to safety, quality, efficacy (performance) or presentation. There are four distinct recall actions - recall, product defect correction, hazard alert and product defect alert.

  • Recall - The permanent removal of an affected therapeutic good from supply or use in the market.
  • Product defect correction - Repair, modification, adjustment or re-labelling of a therapeutic good. The corrective action may take place at the user's premises or any other agreed location.
  • Hazard alert - Information issued to healthcare professionals about issues or deficiencies relating to an implanted medical device or biological product and advice about the ongoing management of patients.
  • Product defect alert - Information issued to raise awareness about issues or deficiencies for a therapeutic good where a recall action will result in interruption of patient treatment or a medicine shortage, including advice to reduce potential risks of using affected goods.
Recall action classification**

Recall actions of therapeutic goods are classified based on the potential risk the deficiency poses to patients/consumers. They are classified as class I, class II or class III.

  • Class I - 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 II - 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 III- A situation in which use of, or exposure to, the deficient therapeutic good(s) is not likely to cause adverse health consequences.
Recall action level

The level to which recall action is to be undertaken. This is based on the significance of the risk and the channels through which the goods have been distributed. The recall action levels are wholesale, hospital, retail and consumer.

  • Wholesale - includes wholesalers and state purchasing authorities.
  • Hospital - includes nursing homes and institutions, hospital pharmacists, ambulance services, blood and tissue banks and laboratories as well as wholesale as appropriate.
  • Retail - includes retail pharmacists, medical, dental and other health care professionals as well as wholesale and hospital as appropriate.
  • Consumer - includes patients and consumers, as well as wholesale, hospital and retail levels as appropriate

Detail notification

This report shows detailed information about a specific recall action that has been selected from the list. It provides greater detail than that which is viewable in the list of recalls.

Headings and definitions
Row heading Definition
Type of product Medicine (including vaccines), medical device or biological
TGA recall reference Unique number given by the TGA
Product name/description Brand name/trade name (including active ingredient for medicines) and may include generic reference for the kind of medical devices. Includes all necessary information such as affected catalogue/model and/or batch/serial numbers.
Recall action level

The level to which recall action has to be undertaken, based on the significance of the risk and the channels through which the goods have been distributed. The levels are given below and are cumulative, e.g. Retail Level, includes Hospital and Wholesale:

  • Wholesale - includes wholesalers and state purchasing authorities.
  • Hospital - includes nursing homes and institutions, hospital pharmacists, ambulance services, blood and tissue banks and laboratories as well as wholesale as appropriate.
  • Retail - includes retail pharmacists, medical, dental and other health care professionals as well as wholesale and hospital as appropriate.
  • Consumer - includes patients and consumers, as well as wholesale, hospital and retail levels as appropriate
Recall action classification**

Recall actions of therapeutic goods are classified based on the potential risk the deficiency poses to patients/consumers. They are classified as class I, class II or class III.

  • Class I - 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 II - 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 III - A situation in which use of, or exposure to, the deficient therapeutic good(s) is not likely to cause adverse health consequences.
Recall action commencement date The date the recall action strategy and communication was agreed by the TGA.
Responsible entity Sponsor/supplier/importer responsible for the recall action.
Reason/issue Reason for the recall action
Recall action**

A recall action is an action taken to resolve a problem with a therapeutic good already supplied in the market for which there are issues or deficiencies in relation to safety, quality, efficacy (performance) or presentation. There are four distinct recall actions - recall, product defect correction, hazard alert and product defect alert.

  • Recall - The permanent removal of an affected therapeutic good from supply or use in the market.
  • Product defect correction - Repair, modification, adjustment or re-labelling of a therapeutic good. The corrective action may take place at the user's premises or any other agreed location.
  • Hazard alert - Information issued to healthcare professionals about issues or deficiencies relating to an implanted medical device or biological product and advice about the ongoing management of patients.
  • Product defect alert - Information issued to raise awareness about issues or deficiencies for a therapeutic good where a recall action will result in interruption of patient treatment or a medicine shortage, including advice to reduce potential risks of using affected goods.
Recall action instructions Information on what customers with affected goods should do.
Contact information Who the customer should contact for additional information and clarification regarding the recall action.

** These definitions are applicable to the current version of the Uniform recall procedure for therapeutic goods (URPTG).

Topics

Help us improve the Therapeutic Goods Administration site