Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon Endo-Surgery alerted U.K. regulators after discovering counterfeit LigaClip surgical clips on the U.S. market that may have also been distributed to U.K. hospitals.
The country’s Medicines & Healthcare products Regulatory Agency issued a medical device alert advising healthcare providers to keep an eye out for potentially forged products.
The counterfeit devices, initially discovered for sale in the U.S. through an unauthorized distributor, may be recognized by shrink-wrapping not used by Ethicon or by strange fonts or typos on the sales unit box, according to the warning.
"The counterfeit product was discovered as a result of an investigation by EES," Ethicon noted in a letter dated June 12. "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 LigaClip devices are permanent surgical closures, applied using a "clip-applier," for sealing off blood vessels without sutures. The effected devices were also distributed in Hong Kong, according to the regulatory warning.
"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.