The March recall of Johnson & Johnson subsidiary Cordis Corp.’s Optease vena cava filter is given the FDA’s highest, Class I designation.
The recall last March of Johnson & Johnson (NYSE:JNJ) unit Cordis Corp.’s Optease vena cava filter is Class I, according to the FDA, meaning the device could cause serious injury or death.
Cordis notified healthcare providers March 29 about 33,000 Optease devices, on concerns that they could be implanted backwards, according to the FDA.
The Miami Lakes, Fla.-based subsidiary notified physicians of corrected labeling “to provide clarification and additional information to minimize likelihood of implanting the filter backwards,” according to an FDA notice.
