Archived - Safety information concerning Tensor Heat Therapy - For the Public

Starting date:

June 1, 2008

Posting date:

June 25, 2008

Type of communication:

Public Communication

Subcategory:

Medical Device

Source of recall:

Health Canada

Audience:

General Public

Identification number:

RA-19000701

This is duplicated text of a letter from BD Canada.

Contact the company for a copy of any references, attachments or enclosures.

Notice about Health Canada advisories

Public Communication

Health Canada Endorsed Important Safety Information on Tensor Heat Therapy Patches

June 2008

Subject: URGENT: PRODUCT RECALL Tensor^TM Heat Therapy Patches All catalog numbers

Dear Valued Customer,

We want to advise you that BD is performing a product recall of all lot numbers and sizes of Tensor^TM Heat Therapy products effective immediately. This recall is being initiated based on consumer reports related to skin irritation and burns. In addition, after reassessing our Home Healthcare product portfolio, BD has decided to withdraw these products from the market and refocus the TENSOR^TM brand on our other traditional areas of strength.

TENSOR^TM Heat Therapy patches are single-time use, instant air-activated heat patches. The affected items are:

• 207808 - TENSOR^TM Heat Therapy vertical 3 pack
• 207810 - TENSOR^TM Heat Therapy vertical 1 pack
• 207813 - TENSOR^TM Heat Therapy vertical bonus 2 pack
• 207815 - TENSOR^TM Heat Therapy vertical bonus 2 pack (Display Pack)
• 207817 - TENSOR^TM Heat Therapy vertical pack (Large)
• 208711 - TENSOR^TM Heat Therapy (Display Pack)

This action does not affect any other TENSOR^TM Brand products.

Please contact the TENSOR^TM Heat Therapy help line at 1-866-315-9591 from Monday to Friday, 8am-6pm EST in order to arrange return and refund of any unused product. Product will be refunded at manufacturer's suggested retail price until August 31, 2008 only. Please note that stores and pharmacies will NOT be accepting consumer returns for this recall.

BD is committed to maintaining the highest product quality standards and to ensuring customer satisfaction. We apologize for this inconvenience and thank you for your continued support of TENSOR^TM products. If you have additional questions or concerns please contact BD-Canada Customer Services via telephone at 1-800-268-5430.

Managing marketed health product-related adverse incidents depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-market adverse incidents are generally presumed to underestimate the risks associated with health product treatments. Any cases of burns or other serious or unexpected adverse incidents in patients using Tensor Heat Therapy should be reported to Becton Dickinson Canada or Health Canada at the following addresses:

BD Canada

2771 Bristol Circle

Oakville, Ontario L6H 6R5

Canada

Tel: 866-979-9408

Fax: 800-565-0897

Any suspected adverse reaction 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

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

For other inquiries related to this communication, please contact Health Canada at:

Marketed Health Products Directorate (MHPD)

E-mail: MHPD_DPSC@hc-sc.gc.ca

Tel.: 613-954-6522

Fax: 613-952-7738

Sincerely,

original signed by

Arthur Kawasaki

Director

Regulatory Affairs & Quality Management

BECTON DICKINSON CANADA INC.