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Important Safety Information on the recall of Segufix-Standard and Segufix-Simplex

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Contact: Medical Devices Bureau Enquiries

The Health Products and Food Branch (HPFB) posts on the Health Canada web site safety alerts, public health advisories, press releases and other notices as a service to health professionals, consumers, and other interested parties. These advisories may be prepared with Directorates in the HPFB which includes pre-market and post-market areas as well as market authorization holders and other stakeholders. Although the HPFB grants market authorizations or licenses for therapeutic products, we do not endorse either the product or the company. Any questions regarding product information should be discussed with your health professional.

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

Health Canada Endorsed Important Safety Information on the recall of SEGUFIX-Standard, Item No. 2201-M and SEGUFIX-Simplex, Item No. 2200-M

March 2006

As you know as a longstanding user of SEGUFIX products, the SEGUFIX System was created to protect the dignity of people who are in need of positioning and restraining. Security and well being of the patient and caregiver are our highest priority.

Recalled products:

  1. SEGUFIX-Standard, Item No. 2201-M (discontinued since 2001, final shipping date October 19, 2001)
    • Patent Lock version only (not Velcro)
    • Side Positioning Straps not integrated (not permanently attached to waist belt)
      Since October 2001 the SEGUFIX Standard has only been shipped with Side positioning straps permanently attached (item no. 2201-MI). This product is not affected by the recall.
  2. SEGUFIX-Simplex, Item No. 2200-M (discontinued since April 2003, final shipping date July 17, 2003)
    • Patent Lock version only (not Velcro)

Reason/ Background:

  1. SEGUFIX-Standard
    Incorrect use of the SEGUFIX-Standard has led to serious injury and in isolated cases to the death of patients in Europe.
    The following actions constitute incorrect use of this product:
    • Side positioning straps were not used
    • Bed side rails were not used
    • Bed side rails were parted, allowing the patient to slip through the gap
    • The recommended 3- or 5-point restraint was not used as required
      To ensure the use of the side positioning straps at all times, SEGUFIX will sew the side positioning straps onto the waist belt for permanent attachment.
  2. SEGUFIX-Simplex
    There is a possible risk to patients if used as a restraint due to the similar appearance with the SEGUFIX-Standard, Item No. 2201-MI.

    To meet conditions set by Health Canada you may either send us your Simplex for credit toward the purchase of a SEGUFIX-Standard, or have them retrofitted with non-removable side positioning straps.

Immediate actions:

  1. Do not use the SEGUFIX Standard or Simplex unless they have been retrofitted with side straps that are permanently attached. During the transitional time of this recall ensure that the SEGUFIX-Standard is always used with side positioning straps.
  2. Please ensure that the enclosed instructions for the SEGUFIX Standard and the SEGUFIX Simplex are reviewed with all potential users and advise users how to avoid displacement of the waist restraint into the area of the thorax emphasizing the following:
    • the importance of applying the side straps
    • raising the bed rails and not using rails of a split design unless the gap is too small to let a person slip through or a solid gap barrier is used that effectively prevents the patient from slipping through the gap.
  3. A variety of accessories, such as hand restraints, foot restraints and thigh restraints are available for the Simplex and Standard designs as well as a shoulder restraint with additional belts for the Standard. Use of these accessories is encouraged to prevent almost any motion if constant or frequent monitoring is not possible.

Recall procedure:

  1. Please complete the attached form and return it to SEGUFIX Systems Ltd.
  2. Upon receipt of the completed form we will provide you with shipping information and a return authorization number.
  3. Send SEGUFIX-Standard restraints along with two side positioning straps for each unit to be sewn onto the waist belt.
  4. For Simplex products, return recalled product for credit toward purchase of a SEGUFIX-Standard, or have them retrofitted with non-removable side positioning straps
  5. Please allow 6 - 8 weeks for the return of the products or to process credits for the SEGUFIX-Simplex.
  6. Recalled products do not have to be sent in all at once. You may choose to spread out the number of shipments.

Exclusion:
SEGUFIX-Standards and SEGUFIX-Simplex that are unsafe due to wear and tear should not be used any more and should be disposed of immediately. These products will not be modified due to safety requirements, nor will there be any credit.

Cost:

  • The side positioning straps will be sewn onto the Standard/ Simplex at no charge to you.
  • You will pay the cost to ship the products to SEGUFIX.
  • SEGUFIX will pay for the return shipping cost.
  • SEGUFIX-Standard only: Missing side positioning straps will be charged at $ 9.80 each for the regular version (item no. 1301-M), and $ 11.27 each for the reinforced version (item no. 1301-MV). Two side positioning straps are needed for each Standard.

Criticality:
SEGUFIX has decided to voluntarily recall the affected product. Health Canada has classified this voluntary recall as Level 2.

We would like to point out that none of the reported accidents were the result of product materials, manufacturer imperfections or of faulty product construction.

We have enclosed a copy of the latest instruction manual for use. Please forward this copy to your education department and to all units that have SEGUFIX-products in use.

SEGUFIX Systems Ltd. has been requested by Health Canada to forward the names of users of the recalled products who have not responded to this recall notice in order for Health Canada to monitor the effectiveness of the recall. We are sorry about the inconvenience. On the other hand we are sure that this recall program will be of assistance to you.

If you have any further questions please call toll free at 1-877-SEGUFIX (734-8349).

For inquiries in French please call our distributor in Quebec, Messrs Dismed Inc., at (514) 355-4711. Geneviève Desormeaux is available to answer your questions or offer further information.

SEGUFIX Systems Ltd.
P.O. Box 234
Canterbury, NB
E6H 2C5
Tel: 1-877-734-8349
Fax: (506) 279-2231
e-mail: info@segufix.ca
Next link will take you to another Web site www.segufix.ca

Any suspected adverse incident can also be reported to:
Health Products and Food Branch Inspectorate
HEALTH CANADA
Address Locator: 2003D
Ottawa, Ontario K1A 0K9
Tel: The Inspectorate Hotline 1-800-267-9675
Fax: (613) 954-0941

The Medical Devices Problem Report Form and Guidelines can be found on the Health Canada web site.

For other inquiries related to this communication, please contact Health Canada at:
Medical Devices Bureau
E-mail: mdb_enquiries@hc-sc.gc.ca
Tel: (613) 957-4786
Fax: (613) 957-7318

With best regards,

original signed by

Roxana Soetebeer
General Manager, Canada
SEGUF/X®-Systems Ltd.

Enclosure:

  • Fax form to be completed
  • SEGUFIX Instruction Manual

To meet conditions set by Health Canada, please complete this form and send it back by

fax: (506) 279-2231
email: info@segufix.ca
mail: SEGUFIX SYSTEMS Ltd. - PO box 234 - Canterbury - NB - E6H 1P9

A response is required even if you have no recalled products in stock.

Quantity of recalled SEGUFIX-Standard, Item no. 2201-M:

Quantity of recalled SEGUFIX-Simplex, Item no. 2200-M:

Name of facility:
Contact name:
Contact phone number:
Contact fax number:
Shipping address:

SEGUFIX Systems Ltd. has been requested by Health Canada to forward the names of users to this recall notice to allow Health Canada to monitor the effectiveness of the recall.

I have read and understood the attached SEGUFIX recall notice.

Signature
Date
Title/ Function

Date Modified: 2011-11-30

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