Uniform recall procedure for therapeutic goods (URPTG), 2004 edition

2004 edition

Book pagination

12 April 2017

Appendix VIII: Example of a recall letter and facsimile reply form

Recall letter

Example of a recall letter for a hospital level recall (similar letters, with appropriate amendments, would be required for retail or wholesale level recall letters to physicians).

<Sponsors letterhead paper>

Chief Executive Officer

<Hospital address>

Attention:

  1. Stores Manager
  2. Director of Nursing

Urgent medical device recall

<Product name> 10cm square surgical dressings, packs of 2

Catalogue number: 46783

Batch numbers: 123, 124, 125, 126 & 128

Order code: 0001884-9873

AUST L xxxxx

<Company name> Pty Ltd, following advice that these batches may not be sterile and after consultation with the Therapeutic Goods Administration, is recalling the above batches of <product name> 10cm Square Surgical Dressings. No other batches or pack sizes of this product are affected by this recall. The batch numbers are displayed on the bottom right hand corner on the front of the packs.

Please inspect your stocks and quarantine all units from the above batch numbers, then complete the attached Facsimile Reply Form and fax it to us so that we may arrange for your stock to be recovered and replacement stock , or a credit note, issued. Please complete the Facsimile Reply Form even if you have no stock which is subject to recall, as we require this information to reconcile this process.

If any of the recalled stock could have been transferred from your hospital to another, please immediately let that hospital know of the recall. It would be appreciated if you would then telephone (long distance callers, reverse charge) us so that we can make contact with the hospital supplied from your hospital.

Please retain this letter in a prominent position for one month in case stock is in transit.

<Company name> Pty Ltd sincerely regrets any inconvenience caused to your hospital.

<signature>

Joe Bloggs
Manager

<Date>

Facsimile reply form

Facsimile reply form

To: <Company name> Pty Ltd
Attention: Joe Bloggs, Manager
Facsimile number: 02 xxxx xxxx
Postal address: PO Box 4, Upper Gralt, NSW 2999
Subject: Recall of <product name> 10cm square surgical dressings, packs of 2, batch numbers: 123, 124, 125, 126 & 128

From:
(name of institution)
Contact person:
(please print)
Telephone No.:
Facsimile No.:

We do/do not have stock which is subject to this recall.

Stock received:

Batch: xxx xxx

Qty: xxx xxx
Batch: xxx xxx Qty: xxx xxx
Unused stock subject to recall (currently in quarantine)
Batch: xxx xxx Qty: xxx xxx
Batch: xxx xxx Qty: xxx xxx
Any other relevant details:
Signature:
Date:

Book pagination