"The counterfeit product was discovered as a result of an investigation by EES," according to the company letter. "It was purchased in the U.S. from an unauthorized distributor. We are working closely with the FDA to investigate this matter and to help prevent further distribution of counterfeit product."
The company added that it’s notifying health authorities worldwide about the matter, as a precaution.
The company caught an illegal distributor selling fake LigaClip Extra ligating clip cartridges, according to a notice dated June 12, 2012. The effected devices were also distributed in Hong Kong, according to a regulatory warning.
The LigaClip devices are permanent surgical closures, applied using a "clip-applier," for sealing off blood vessels without sutures.
"Because EES did not manufacture these products, we cannot confirm the performance, mechanical properties, biocompatibility or sterility of these clips," according to the letter. "All healthcare professionals should carefully examine all LigaClip products before use."
It’s not the 1st time Johnson & Johnson has discovered counterfeiters. In June of 2011 the company cracked down on a South African distributor accused selling fake OneTouch diabetes test strips.
Ethicon did not respond to requests for comment.