J&J Warns Physicians About Counterfeit Medical Device
Posted 14 June 2012 | By
Life sciences manufacturer Johnson & Johnson's subsidiary Ethicon this week warned physicians about counterfeit copies of its Ligaclip Extra Ligating Clip Cartridges, which are used for tubal ligation.
The company explained in a "Dear Healthcare Provider Letter" that its investigators had discovered counterfeit copies of the device in at least two countries-the US and Hong Kong-and the company was working with regulatory authorities in both countries to track the source of the copies. Ethicon said copies of the device had entered the supply chain in the US, but it is unclear whether the device was manufactured in the US or abroad.
It is at least the second instance of Ethicon finding counterfeit copies of the product in its global supply chain.
In a 7 June 2010 "Dear Healthcare Professional" letter, Ethicon said it discovered counterfeit copies of its Proximate PPH Hemorrhoidal Circular Stapler after receiving a complaint from a consumer in Italy. The company said it was working with Italian authorities and the Italian Ministry of Health to investigate how the counterfeit medical device entered the supply chain, and was working to "prevent further distribution of counterfeit product."
"Because EES did not manufacture this product, we cannot confirm the performance, mechanical properties, biocompatibility or sterility of this device," explained Ethicon in its letter. "We are informing healthcare professionals of this situation so you can take the appropriate preventative action to help ensure patient safety."
At the time, the company was only aware of the product having entered the Italian supply chain.
"Dear Healthcare Professional" Letter from Ethicon
h/t Mass Device - Ethicon warns on counterfeit surgical clips on the U.S. market