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Non-sterile Assut Sutures AssuCryl and Silk Surgical Sutures

Notice type: Advisory

Date: 19/08/2011

  

Product name or type:
Non-sterile Assut Sutures AssuCryl and Silk Surgical Sutures

Reference:
SN2011(21)

Manufacturer Or Supplier:
Assut Medical Sàrl

Target Audience:
Hospital Managers / CEOs 
Risk Managers 
Clinical Directors 
Clinical Engineers 
Surgeons 
Theatre and Nursing Staff 
Purchasing Managers 
Nursing Managers 
Emergency Departments 
Hospital personnel 
Medical device distributors 

Problem Or Issue:
Stolen non-sterile Assut Sutures AssuCryl and Silk surgical sutures are labelled as “Sterile”.

Background Information Or Related Documents:
Assut Medical Sàrl notified the Irish Medicines Board of a stolen shipment of two boxes containing multiple lots of the Assut Sutures AssuCryl and Silk surgical sutures. These devices are identified on their labelling as being sterile. However, the boxes were stolen before the lots were sterilised and are therefore non-sterile. Use of these non-sterile devices may lead to infection. 
The stolen boxes included all devices from the specific lot numbers listed in table 1. The devices that were stolen were in bulk boxes and were not in the sales packaging used for the device, which contain either 1 or 3 dozen devices. 
The boxes were stolen in Columbia the 29th July 2011 and it is not known if the products have left or will leave Columbia. As a precautionary measure, Assut Medical Sàrl will be informing its customers worldwide about the issue. Assut Medical have never sold these devices in Ireland. 

Non-sterile Assut Sutures AssuCryl and Silk Surgical Sutures 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 Assut Medical Sàrl. 
• 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 
Website: www.hpra.ie 

Enquiries to the manufacturer should be addressed to: 

Assut Medical Sàrl 
Av. de Rochettaz 57 
1009 Pully 
Switzerland 

Contact person: Catherine Baerfuss 
Telephone: +41 21 728 64 35 
Fax: +41 21 728 64 49 
E-mail: cba@assutsutures.com 

Please click here to download PDF version of safety notice 

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