Revised: 14 January 2016

Safety Information

Recall Action Definitions

There are many terms that are used to describe the various types of corrective actions, the significance of the recall action, the action to be taken, and the extent through the supply chain the action is to be completed. These terms are explained below.

Recall actions often target a specific group of product such as a particular lot or batch, serial number range, or software version. Products that are outside of that specific group will not be affected by the recall action.

Types of Recall Action

A recall action does not necessarily mean that the product is being withdrawn from the market. There are several types of recall actions that can occur which are linked to different types of therapeutic products. It may not be practical to replace a product however it may be modified or updated in response to a recall action.

Explanations of the various types of recall actions are provided in the table below:

Recall	Recall means the removal of affected therapeutic product(s) from supply or use for reasons relating to deficiencies in the safety, quality, efficacy or performance of the products
Recall for Product Correction	Medical Devices only Recall for Product Correction advises of the sponsor's / manufacturer's intention to repair, modify, adjust, re-label or provide updated instructions for use. This action would be for reasons relating to deficiencies in the safety, quality, efficacy or performance of the affected products. The corrective action may take place at the user's premises (field correction) or the sponsor's premises or any other agreed location and may involve a period of quarantine
Hazard Alert	Implanted Medical Devices Only Hazard Alert means the issuing of precautionary information to healthcare professionals about an implanted medical device. This may be related to a safety, efficacy, quality or performance related condition pertaining to that product. The information supplied may: describe situations to be aware of advise of potential complications that may have arisen since the device / product was implanted provide advice regarding clinical management. A hazard alert may also be issued in conjunction with a notice recalling all un-implanted devices / products.
Product Alert	Medicines Only A Product Alert may be issued in response to a situation where some form of market action is required but a product recall may put the patient at greater risk; ie, no alternative product is available and the risk to the patient of no product is greater than the risk to the patient of using the affected product.

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Significance of recall action

Recall actions are rated according to the significance of the issue on the health of the patient or user of the therapeutic product.

Class I recalls occur when the defect identified in the product is potentially life-threatening or could cause a serious risk to health.

Class II recalls occur when the defect identified in the product could cause illness or incorrect treatment but the risk is not considered serious enough to be Class I.

Class III recalls occur when the identified defect in the product may not pose a hazard to health but where a recall action has been initiated for other reasons, and the risks are not considered to be Class I or II.

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Level of recall action

A recall action is conducted to an agreed level in the supply chain depending on the distribution of the product and the severity of the issue. The various levels of recall action are described below:

Consumer Level	patients and other consumers will also include; Wholesale, Hospital/Laboratory, Healthcare Professional and Pharmacy/Retail levels
Pharmacy / Retail Level	community pharmacies medical, dental and other health care practices other general retail outlets, e.g. supermarkets and health food stores will also include; Wholesale, Hospital/Laboratory, and Healthcare Professional levels
Hospital / Laboratory Level	hospitals including private hospitals and residential care facilities nursing homes and other health care facilities clinical trial sites hospital pharmacies, blood banks, pathology laboratories personnel in other hospital departments will also include: Wholesale and Healthcare Professional levels
Healthcare Professional Level	surgeons consultants specialists dentists pharmacists general practitioners nurse practitioners any healthcare professional supplying, prescribing or using an affected medicine or supplying, using, monitoring, checking or having implanted a medical device may also include other levels
Wholesale Level	medicine and medical device wholesalers, suppliers and third party logistics companies (where product is held by a third party for distribution to retailers or other organisations before being supplied to end users)

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