Jul 07, 2023
Ethicon warns on counterfeit surgical clips on the U.S. market
June 13, 2012 By MassDevice staff Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon Endo-Surgery warned healthcare providers this week that it discovered counterfeit LigaClip surgical devices in
June 13, 2012 By MassDevice staff
Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon Endo-Surgery warned healthcare providers this week that it discovered counterfeit LigaClip surgical devices in distribution in the U.S.
"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.
Filed Under: News Well, Recalls, Surgical Tagged With: Ethicon, Johnson and Johnson