Recall on Dahedi Insulin Pumps

Date: 2003-11-06

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Contact
MHPD-DPSC

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This is duplicated text of a letter from Disetronic Medical Systems, Inc.
Contact the company for a copy of any references, attachments or enclosures.

Disetronic Medical Systems, Inc.
5151 Program Avenue
St. Paul, MN 55112-1014
800-280-7801
763-795-5200
Fax 763-795-5300
http://www.disetronic-usa.com

03-160
08/25/03
Canada

Physician/Healthcare Provider - Urgent Product Recall on Dahedi Insulin Pumps

Introduction

Following an inspection of our infusion pump manufacturing facility, the U.S. Food and Drug Administration (FDA) determined that our manufacturing processes are not in substantial compliance with the regulations. In the absence of compliance with these regulations, the reliability of devices cannot be assured, which could potentially result in problems with the product leading to under and/or over infusion of insulin. Health Canada has asked that we inform you of this issue.

We are removing all of our Dahedi pumps immediately. However, we will allow you to continue using this pump with your patients until they have received and been properly trained on a new pump we will be providing.

This letter, together with a copy of the Urgent Product Recall communication (03-158) that has been sent to patients, is being sent to all physicians who have prescribed a Dahedi pump and to all Certified Dahedi Pump Trainers.

Actions

• Please review the enclosed communication (03-158) that has been sent to patients. It is our intent to provide you with as much information as possible so that you are fully informed and able to discuss this issue with your patients if/when questions arise.
• Please DO NOT prescribe a Disetronic pump to any new patients at this time. We will notify you when you can resume prescribing other Disetronic pumps with the reliability that your patients deserve.
• Disetronic is working closely with Health Canada to resolve these issues.

Questions

Disetronic deeply regrets any inconvenience this situation may cause, and is committed to supporting our existing customers by providing disposable pump supplies, as well as ongoing support. Please call 1-866-703-3476 (toll free) if you have questions about the information contained in this letter or concerns about your patients using a Disetronic infusion pump.

Any suspected adverse incident can also be reported to:
&Food Branch Inspectorate
HEALTH CANADA
Address Locator: 3002C
OTTAWA, Ontario, K1A 0K9
Tel: The Medical Devices Hotline 1-800-267-9675