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 recall affects catheters with product codes TC033 and TC043, and the firm asked that customers return all unexpired, unused Thermachoice catheters that are part of Gynecare Thermachoice III systems.
Ethicon said it will refund any devices returned before February 26 but will not accept any components other than the specifically recalled catheter.
The firm said it has contacted the FDA to inform the agency of the recall.
The post J&J’s Ethicon recalls Gynecare Thermachoice III cath on shelf life issues appeared first on MassDevice.
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