June 8, 2012 - Ethicon Endo-Surgery (EES) recently became aware of the distribution of counterfeit LIGACLIP EXTRA LIGATING CLIP CARTRIDGES (Product Code LT300).
Because EES did not manufacture these products, we cannot confirm the performance, mechanical properties, biocompatibility or sterility of these clips. We are informing you so you can take preventive action to help ensure patient safety. All healthcare professionals should carefully examine all LIGACLIP Products before use.
Please convey this information to your staff and any others who use LIGACLIP Products in the operating room so they will be able to identify the characteristics of a suspected counterfeit product.
If you receive any product that you suspect is counterfeit, do not use it. Quarantine the product to ensure it will not be used. Contact your local EES representative, as EES may be able to help you determine if the product is authentic.
If you determine the product is counterfeit, please contact the U.S. Food and Drug Administration (FDA) through MedWatch. Instructions for reporting are available at http://www.fda.gov/Safety/MedWatch/HowToReport/default.htm.
The counterfeit product was discovered as a result of an investigation by EES. It was purchased in the United States from an unauthorized distributor. We are working closely with the FDA to investigate this matter and to help prevent further distribution of counterfeit product. As a precaution, we are also notifying appropriate legal and health authorities worldwide.
EES takes measures to help ensure the integrity of the products we provide through our supply chain by selling directly to customers or through authorized distributors. EES strongly discourages the purchase of products from unauthorized distributors and will not warrant or assume liability for any products purchased from unauthorized distributors.
The authentic EES sales unit box is not shrink wrapped.
The authentic EES product clearly indicates the company name "Johnson & Johnson Company" on the sales unit box.
The counterfeit product sales unit box is shrink wrapped. The authentic box is not.
An unusual font on the sales unit box distorts the "Johnson & Johnson company" branding on the package.
Authentic EES individual clip packages are correctly labeled, with the word "STERILE" on the package.
The counterfeit product has the incorrect spelling "STEMIKE."
On counterfeit individual clip packages, the word "STERILE" is misspelled "STEMIKE."