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Counterfeit Ethicon Endo-Surgery (EES) LIGACLIP® EXTRA LIGATING CLIP CARTRIDGES

Notice type: Advisory

Date: 18/06/2012

  

Product name or type:
Counterfeit Ethicon Endo-Surgery (EES) LIGACLIP® EXTRA LIGATING CLIP CARTRIDGES. Product Lot: LT300

Reference:
SN2012(05)

Manufacturer Or Supplier:
Ethicon Endo- Surgery LLC 
Guaynabo, 
Puerto Rico 00969 
USA 

Target Audience:
General Surgeons 
Theatre and Nursing Staff 
Purchasing Managers 
Nursing Managers 
Consultant General Surgeons 
Hospital Managers / CEOs 
Clinical Directors 
Risk Managers 
Hospital Personnel 
Clinical Engineers 
Patients 

Problem Or Issue:
The supply and use of counterfeit LIGACLIP® EXTRA LIGATING CLIP CARTRIDGES that are not guaranteed to meet the required standards of safety and quality, as required by the medical devices legislation.

Background Information Or Related Documents:
Ethicon Endo-Surgery (EES) recently became aware of the distribution of counterfeit LIGACLIP® EXTRA LIGATING CLIP CARTRIDGES (Product Code LT300). The exact risks associated with the use of the counterfeit product are unknown. As the counterfeit product was not manufactured by EES they cannot confirm the performance, mechanical properties, biocompatibility or sterility of the counterfeit products. 

The counterfeit product was discovered as a result of an investigation by EES. The product was purchased in the United States from an unauthorised distributor. EES are working closely with the FDA and EU regulators to investigate this matter. As a precautionary measure EES is notifying all customers of the issue. 

Attached is the letter that EES is sending to all of its customers. The letter details the differences that EES has identified between the counterfeit devices and the genuine devices: 

1. The counterfeit product sales unit box is shrink wrapped. 

2. An unusual font on the sales unit box distorts the company name. 

3. Individual clip package misspells “STERILE” as “STEMIKE.” 

Further details and images may be found in attachment A. 

The manufacturer, EES, strongly discourages the purchase of products from unauthorized distributors. It recommends that all products are purchased directly from EES or an authorised distributor. EES can be contacted by calling Eimear Butler, Regulatory Affairs Associate, Johnson & Johnson Medical Ltd Ireland Tel.: 01 4665286. 

Counterfeit Ethicon Endo-Surgery (EES) LIGACLIP® EXTRA LIGATING CLIP CARTRIDGES Document

Actions To Be Taken:
The IMB advises that: 

• All products in your possession should be checked using the details above to 
assess whether the product is genuine or counterfeit. 

• If from your assessment, you determine or suspect that you have product that 
is counterfeit; identify, locate and quarantine all products to ensure it will not 
be used. 

• Contact your local EES representative, as EES may be able to determine if the 
product is authentic. 

• If it is determined to be counterfeit, advise the IMB immediately that you 
have identified counterfeit products by emailing devicesafety@hpra.ie.

Further Information:
ENQUIRIES 
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: devicesafety@hpra.ie
Website: www.hpra.ie

Enquiries should be addressed to: 

Local Johnson & Johnson Medical Ltd Office: 
(EES is part of the Johnson & Johnson Group of Companies) 

Eimear Butler 
Regulatory Affairs Associate. 
Johnson & Johnson Medical Ltd. 
Airton Road 
Tallaght 
Dublin 24 

Tel.: 01 4665286 
Fax: 01 4665340 

Click here to view PDF Version of this Safety Notice

Click here to view Attachment A

Click here to view Counterfeit Notice

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