Boston Scientific Urgent Device Notification - Non-Sterile Devices Stolen and Risk of Infection - Notice to Hospitals

Starting date:

May 3, 2011

Posting date:

May 25, 2011

Type of communication:

Notice to Hospitals

Subcategory:

Medical Device

Source of recall:

Health Canada

Audience:

Healthcare Professionals

Identification number:

RA-170002444

This is duplicated text of a letter from Boston Scientific.

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

Notice about Health Canada advisories

Notice to Hospitals

Health Canada Endorsed Important Safety Information on Non-Sterile Devices Stolen and Risk of Infection

May 3, 2011

Dear Risk/Materials Manager and Healthcare Professional:

Please distribute to the relevant Departments of Surgery; Emergency Medecine, Anesthesia, Geriatrics, Internal Medicine, Nursing, Intensive Care and/or other Departments as required and other involved professional staff and post this NOTICE in your institution.

Subject: Urgent Device Notification - Non-Sterile Boston Scientific Devices Stolen and Risk of Infection

Boston Scientific Corporation is alerting you about a stolen shipment of Endoscopy and Urology / Women's Health medical devices. These devices were stolen while en route to our sterilization facility sometime between April 8, 2011 and April 11, 2011.

The labels on these devices state that they are "Sterile"; however, they were stolen prior to being sterilized and are non-sterile. Use of these non-sterile devices may lead to infection.

Required Actions

• Check your inventory for affected product
• Segregate
• Monitor all incoming shipments for affected product

It is recommended that health care professionals monitor and treat patients for adverse events, such as post-operative infection, if they suspect or know that the below stolen non-sterile devices have been used.

Only the specific UPNs and Batches identified in the table below are affected. If you have any of these identified devices in your current inventory or receive any future delivery of these batches of devices, please do not use the devices and contact John Zagala (Quality Assurance) at Boston Scientific at (905) 696-1923 or via email at john.zagala@bsci.com.

Please visit our website at www.bostonscientific-international.com or www.bostonscientific.com for information on device labeling, device photos and other additional information concerning this issue.

Health Canada has been notified of this issue and is working with the Boston Scientific Corporation to recover these stolen devices.

Your vigilance related to any suspicious transactions relating to the devices listed above is greatly appreciated. For example unusually low pricing may be an indication that the product has been stolen.

Anyone who has information regarding this incident or has received suspicious or unsolicited offers for the devices identified above, after the date of the theft, is encouraged to contact John Zagala (Quality Assurance) at Boston Scientific at (905) 696-1923 or via email at john.zagala@bsci.com.

Boston Scientific

5060 Spectrum Way, Suite 500A

Mississauga ,

Ontario, L4W 5N5

Telephone: 905-696-1923

Any suspected adverse incident can also be reported to:

Health Products and Food Branch Inspectorate

HEALTH CANADA

Address Locator: 2003D

Ottawa, Ontario K1A 0K9

Telephone: The Inspectorate Hotline 1-800-267-9675

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

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

Marketed Health Products Directorate

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

Telephone: 613-954-6522

Fax: 613-952-7738

To change your mailing address or fax number, contact the Market Authorization Holder (Industry).

If you have questions or concerns regarding the affected devices, contact the person named above at Boston Scientific.

Sincerely,

original signed by

John Zagala

Quality Assurance Canada

(905) 696-1923

(905) 696-1896