Johnson & Johnson's Ethicon Recalls Gynecare Thermachoice III Cath on Shelf Life Issues
Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon said it is recalling its Gynecare Thermachoice III thermal balloon ablation silicone catheters over issues with the labeled 2-year shelf life.
The company said that “stability data” does not substantiate the 2-year labeling, but said there is no significant safety issue with the device itself, and that the recall doesn’t have any impact on the outcome of performed procedures.
The recall only affects the catheter component of the system, Ethicon said.
The company said that “stability data” does not substantiate the 2-year labeling, but said there is no significant safety issue with the device itself, and that the recall doesn’t have any impact on the outcome of performed procedures.
The recall only affects the catheter component of the system, Ethicon said.