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Non-sterile Boston Scientific Endoscopy and Urology / Women’s Health Devices Stolen

Notice type: Advisory

Date: 13/05/2011

  

Product name or type:
Non-sterile Boston Scientific Endoscopy and Urology / Women’s Health Devices Stolen

Reference:
SN2011(08)

Manufacturer Or Supplier:
Boston Scientific Corporation

Target Audience:
Hospital Managers / CEOs 
Risk Managers 
Clinical Directors 
Clinical Engineers 
General Surgeons 
Urological Surgeons 
Gynaecological Surgeons 
Gastrointestinal Surgeons 
Gastroenterologists 
Obstetricians 
Endoscopy units 
Theatre and Nursing Staff 
Purchasing Managers 
Nursing Managers 
Emergency Departments 
Hospital personnel 
Medical device distributors

Problem Or Issue:
Stolen non-sterile Boston Scientific Endoscopy and Urology/Women’s Health products are labelled as “Sterile”.

Background Information Or Related Documents:
Boston Scientific Corporation has issued an alert informing customers of a stolen shipment of several Endoscopy and Urology/Women’s Health products. These devices were stolen while en route to the sterilisation facility sometime between April 8, 2011 and April 11, 2011. The pre-printed 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. 
It is not known if the products have left or will leave the USA. As a precautionary measure, Boston Scientific will be informing its customers worldwide about the issue. 
Only specific UPNs (Material/Catalog Number) and Batches identified in the table below are affected. 

Non-sterile Boston Scientific Endoscopy and Urology / Women’s Health Devices Stolen Document

Actions To Be Taken:
The IMB advises that you: 

• Check your inventory for the affected product 
• Monitor all incoming shipments for the affected product 
• If you have any of these identified devices in your current inventory or receive any future delivery of these batches of devices, do not use the devices and contact Boston Scientific 
• If healthcare professionals suspect or know that the stolen non-sterile devices have been used, it is recommended that they monitor and treat patients accordingly. 

Further Information:
If you have any enquiries relating to the above you may contact the Medical Devices Vigilance & Compliance section of the Human Products Monitoring Department of the Health Products Regulatory Authority at the contact details listed below. 

All adverse incidents relating to a medical device should be reported to the: 

Health Products Regulatory Authority
Kevin O’Malley House 
Earlsfort Centre 
Earlsfort Terrace 
Dublin 2 

Telephone: +353-1-6764971 
Fax: +353-1-6344033 
E-mail: vigilance@imb.ie 

Enquiries to the manufacturer should be addressed to: 

Boston Scientific Ltd 
Breakspear Park 
Breakspear Way 
Hemel Hempstad 
Herts HP2 4TZ 

Contact person: Cait Gatt 
Telephone: +44 1442 411673 
Fax: +44 1442 411816 
E-mail: Cait.Gatt@bsci.com 

Click here to download a PDF version of the Safety Notice

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