Information for Medical Device Suppliers
Drafting a Corrective Action Notice
Corrective actions are communicated to the affected customers via corrective action notices. These notices should be reviewed by Medsafe prior to being distributed to customers/users for appropriateness and to ensure compliance with the Uniform Recall Procedure. Draft templates for key types of corrective actions are available for download.
Download the Uniform Recall Procedure Code (Adobe PDF document 995 KB)
All corrective action notices should include the following information;
- Brand, model, and name of the affected device(s)
- The unique identifier - part number, catalogue number, stock code, etc - of the affected device(s)
- The reason for the corrective action
- The risk posed to patients and/or users by the affected device(s)
- Details of the proposed corrective action
- An acknowledgement form for the customer to complete and return
- A local New Zealand telephone number (preferably an 0800 free-call number) that customers can contact for further information
- A local New Zealand fax number (preferably an 0800 free-call number) that customers can return acknowledgement forms to
- A statement to the affect that this action is being conducted in consultation with Medsafe, Ministry of Health
- (Recommended) The WAND number of the affected device(s)
- (Optional) The Medsafe reference number for the corrective action
Sponsors are reminded that a corrective action is conducted for reasons of product safety and should not contain information that is not essential to the customer. It is inappropriate to downplay the significance of the issue, or to include marketing information with the corrective action notice.
Medsafe expects all corrective action notices to be distributed with an acknowledgement form for the customer to complete and return. For alerts the acknowledgement form is a confirmation that the affected customer(s) has/have received the notice. In recalls and product corrections the acknowledgement form will be used to obtain information from the customer, such as confirming the number of affected devices.
Sponsors should include a draft acknowledgement form with their corrective action notices when submitting them to Medsafe for review.
Sponsors are expected to track the return of acknowledgement forms and to attempt to obtain a 100% response from the affected customers.
Corrective Action Templates
Medsafe has prepared several templates that sponsors can use or refer to when drafting their corrective action notices. These templates are based on the guidance provided in the Uniform Recall Procedure.
Wording in italics and enclosed in square brackets [such as this] is used to indicate what information the sponsor should insert at that point, replacing the brackets and text in italics.
Use of these templates is optional. Sponsors with their own corrective action notice templates may continue to use their own forms, having ensured they comply with the guidance provided in the Uniform Recall Procedure.
Draft corrective action documents should then be submitted to Medsafe for review prior to distribution to the affected customers.
Download the Medical Device Recall notice template (Microsoft
Word document 39 KB)
Download the Medical Device Recall for Product Correction notice template (Microsoft Word document 40 kB)
Download the Safety/Hazard Alert template (Microsoft Word document 35 kB)
Page last updated 10 May 2011