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Wallach LL100 Cryosurgical System CO2 and Accessories

Notice type: Advisory

Date: 18/02/2010

  

Product name or type:
Wallach LL100 Cryosurgical System CO2 and Accessories

Reference:
SN2010(01)

Manufacturer Or Supplier:
Wallach Surgical Devices / Cooper Surgical Inc.

Target Audience:
General Practitioners 
Practice Nurses 
Hospital risk managers 
Clinical Nurse Specialists 
Hospital consultants including: 
Dermatologists 
Plastic surgeons 
Public health consultants 
Genito-Urinary medicine 
General surgical consultants 
Gynaecologists 
Infectious disease specialists 

Problem Or Issue:
A manufacturing problem has been detected where under certain circumstances a restriction of the flow of carbon dioxide gas within the handle may result in a less than optimum temperature delivery to the treatment site.

Background Information Or Related Documents:
During September 2009, Wallach Cryosurgical issued a field safety notice (FSN) to advise customers of the recall of Wallach Surgical CO2 based Cryosurgical Instruments due to a manufacturing problem which was identified during internal testing. The manufacturer confirmed that Nitrous Oxide (N2O) Cryosurgery Devices are not affected and should continue to be used. 

The Irish Medicines Board (IMB) is aware that these cryosurgical units have been placed on the market in Ireland and while it is believed that Irish customers use nitrous oxide in the operation of the cryosurgical system, which is unaffected by this issue, the IMB is issuing this safety notice to ensure all Wallach Surgical cryosurgical system users are aware of the issue as described in the attached FSN.

Wallach LL100 Cryosurgical System CO2 and Accessories Document

Actions To Be Taken:
1) Ensure the appropriate personnel are made aware of this notice. 

2) Identify the location of all Wallach LL100 Cryosurgical System CO2 and Accessories. 

3) Follow the instructions outlined in the attached FSN from Wallach Surgical regarding this action. 

Further Information:
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 

Enquiries to the manufacturer should be addressed to: 

Manufacturer - 
Wallach Surgical Devices 
235 Edison Road 
Orange, CT 06477 
USA 

Telephone: +1-203-799-2000 
Fax: +1-203-799-2002 


Or 

Authorized European representative: 
Leisegang Feinmechanik-Optik GmbH 
Leibnizstr. 32 
D-10625 Berlin 
Germany 

Telephone: +49-30-319-009-53 
Fax: +49-30-313-599-2 


Contact person: Mr. Norman Popp-Lange 

Download: Field Safety Notice

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