Recall / Field Safety Notice (procedure)

This page contains information about the procedure that needs to be followed in case you want to report a recall, Field Safety Notice (FSN), or an end-of-life or –service notification (EOL/EOS resp.) for medical devices and medication to our organization. You have to report these notifications in writing, by e-mail and sometimes also by mail.

The procedure

For medical Devices

To notify our organization of a field safety notification (including recalls) for medical devices (including software), address the notification per e-mail to:

Quality Assurance & Regulatory Affairs bureau
Afdeling Medische Technologie
t.n.v. FSN-coördinator
recall@erasmusmc.nl

After receiving a notification it is assigned to a specialist within our organization. For an integral oversight of all vigilance matters, including recalls, it is important that these notifications are not sent to individuals within our organization. If you have any questions, please contact recall@erasmusmc.nl for more information.

For medication

Send your notification by mail and per e-mail to:

QA-apotheker en Logistiek apotheker
Erasmus MC Ziekenhuisapotheek
Postbus 2040
3000 CA Rotterdam

qa.apotheek@erasmusmc.nl en logistiekapotheek@erasmusmc.nl

What information should be included in a recall / FSN?

To be able to properly address any notification, the following information should be provided:

1. Name/title:

The notification should have a clear title. In the case of a recall or FSN, the notification should have a distinct reference number.

2. Type of notification

It should be stated what type of notification it is. For example a recall or an End-Of-Life or –Service notification.

3. Product(s) that is/are affected by the notification:

Product description(s)
Article code(s) / -type(s)
Lot number(s)/ Serial number(s)

4. In case of a recall: an overview of the products that have been delivered to the Erasmus MC*:

Order number(s) of supplier and Erasmus MC
Per order number:
- Date of delivery
- Article code(s) / -type(s)
  Per article code / -type
  - Lot number(s) / serial number(s)
  Per lot number
  - Number of delivered products

5. Description of:

a. The reason for the notification
b. The determined (possible) risks when the product is (continued to be) used*

6. Action(s) that need to be taken

a. By the Erasmus MC
b. By the manufacturer (including collecting the products from the organization)*

7. Contact information for communication about the notification

8. Whether the IGJ has been notified of the situation*

* (predominantly) Relevant in the case of a Field Safety Notification.